CN114080197A - Dental appliance and related manufacturing method - Google Patents

Abstract

Orthodontic appliances and methods of making the same are disclosed. Manufacturing the appliance may include obtaining position data related to an Original Tooth Arrangement (OTA) of the patient's teeth, obtaining data corresponding to a desired Final Tooth Arrangement (FTA) of the patient's teeth, and determining a displacement between the OTA data and the FTA data. Based on the determined displacement, a configuration of the orthodontic appliance is determined. The appliance includes an anchor configured to be positioned adjacent a tooth, and a plurality of arms each extending away from and coupled to the anchor, the arms configured to be secured to the patient's tooth. When the appliance is installed, the arms push the individual teeth from the OTA to the FTA.

Description

Dental appliance and related manufacturing method

RELATED APPLICATIONS

This application claims priority from united states provisional application No. 62/842,391 filed on 2/5/2019, the disclosure of which is incorporated by reference in its entirety.

This application is also related to the following applications, each of which is incorporated by reference in its entirety: united states provisional patent application No. 62/956,290, filed on 1/2020; U.S. patent application No. 16/865,323, entitled dental appliances, systems, and methods, filed on 2/5/2020; international patent application No. PCT/US20/31211, entitled dental appliances, systems and methods, filed on 2/5/2020; U.S. patent application No. 15/929,443, entitled dental appliance and related systems and methods of use, filed on 2/5/2020; U.S. patent application No. 15/929,444, entitled dental appliance and related systems and methods of use, filed on 2/5/2020; and international application number PCT/US20/70017, filed on 2.5.2020, entitled dental appliance and related systems and methods of use.

Technical Field

The present application relates to the field of orthodontics (orthodontics), and more particularly, to devices, systems, and methods for designing and manufacturing orthodontic appliances (orthodontics applications).

Background

A common goal of orthodontics is to move a patient's teeth to a position where the teeth function optimally and are aesthetically pleasing. To move a tooth, an orthodontist (orthodontist) first takes a plurality of scans and/or impressions (imprints) of the patient's tooth to determine a series of corrective paths between the initial position and the ideal final position of the tooth. The orthodontist then causes the patient to install one of two main appliance types: braces (brace) or aligners (aligner).

Conventional braces consist of brackets (brackets) and archwires (archwires) disposed across the front sides of the teeth, the archwires being secured to the brackets with elastomeric ties (elastic ties) or ligatures (ligature wires). In some cases, self-ligating brackets may be used in place of the bands or wires. The shape and stiffness of the archwire, and the interaction of the archwire with the brackets, determine the force applied to the teeth and thus the direction and extent of tooth movement. Orthodontists often manually bend the archwire in order to apply the required force on the teeth. The orthodontist monitors the patient's progress of treatment by regular visits during which the orthodontist visually assesses the progress of treatment and manually adjusts the archwire (such as to make a new bend) and/or replaces or repositions brackets. The adjustment process is time consuming and tedious for the patient and often results in patient discomfort within a few days after the visit. In addition, the mouthpiece is aesthetically unappealing and makes brushing, flossing and other dental hygiene procedures difficult.

The aligner includes a transparent, removable polymeric housing having a cavity for receiving and repositioning the teeth to produce a final tooth arrangement. Aligners known as "invisible braces" provide patients with a significantly better aesthetic result than braces. The aligner does not require the orthodontist to bend the wire or reposition the brackets and is generally more comfortable than a mouthpiece. However, unlike braces, aligners are not effective in treating all malocclusions. Certain tooth repositioning steps, such as eruption (rotation), translation, and certain rotations, may be difficult or impossible to achieve using an aligner. Furthermore, since the calibrator is detachable, the success or otherwise of the treatment depends largely on patient compliance, which can be unpredictable and inconsistent.

Lingual braces are alternatives to aligners and conventional (buccal) braces and have become increasingly popular in recent years. Two examples of existing lingual braces are Incogenoto^TMOrthotic system (3M USA) and

(Swift Health Systems, Owen, Calif.), each includes a bracket and an archwire that is placed either lingual or lingual to the teeth. Compared with the traditional tooth socket, the tooth socket on the lingual side is almost invisibleMoreover, unlike aligners, lingual braces are fixed to a patient's teeth and force patient compliance. However, these prior lingual techniques also have some drawbacks. Most notably, conventional lingual aligners still rely on the bracket archwire system to move the teeth, thus requiring multiple revisions and painful adjustments. For example, lingual techniques have relatively short internal bracket spacing, which generally makes the archwire more flexible. Thus, the entire lingual aligner is more sensitive to archwire adjustment, causing more pain to the patient. In addition, the lingual side of the appliance can irritate the tongue, affect speech, and make the appliance difficult to clean.

Accordingly, there is a need for improved orthodontic appliances.

Disclosure of Invention

The subject technology is illustrated in accordance with various aspects described below, including with reference to fig. 1A-18. For convenience, examples of various aspects of the subject technology are described as numbered bars (1, 2,3, etc.). These are provided as examples and do not limit the subject technology.

Article 1a method of making an orthodontic appliance, comprising:

data corresponding to an original dental arrangement (OTA) of a patient's teeth is acquired,

acquiring data corresponding to a desired Final Tooth Arrangement (FTA) of a patient's teeth;

determining a displacement between the OTA data and the FTA data;

determining a configuration of the orthodontic appliance based on the determined displacement, comprising:

an anchor configured to be positioned adjacent a patient's tooth; and

a plurality of arms, each arm extending away from and coupled to the anchor, the arms configured to be secured to a patient's tooth,

wherein the arms urge the individual teeth of the patient from the OTA to the FTA when the appliance is installed.

Article 2 the method of any one of the articles herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a displacement between the OTA data and the FTA data.

Article 3 is a method according to any of the articles, wherein determining a configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a surface of a periodontal ligament (a periodontal ligament) or a root area (area) of one or more teeth.

The method of any of the preceding 4, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a bone density of the patient.

Clause 5 is a method according to any of the aspects herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising one or more biological determinants (biological determinants) obtained from saliva, gingival crevicular fluid, blood, urine, or mucosa of the patient.

The method of any of the previous clauses, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising the gender of the patient.

Article 7 is a method according to any of the articles, wherein determining a configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising an ethnicity (ethnicity) of the patient.

Article 8 is a method according to any of the articles herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising the age of the patient.

Article 9 is a method according to any of the articles, wherein determining a configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a jaw (jaw) to which the appliance is to be installed.

The method of any of the previous clauses 10, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising a number of teeth to which the appliance is to be attached.

Article 11 the method of any one of the articles, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data comprising mechanical properties (mechanical properties) of bone and tissue (lips, tongue, and/or gums) adjacent the tooth to be moved to generate output data corresponding to the configuration of the orthodontic appliance.

The method of any of the previous clauses, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a design of one or more arms.

The method of any of the previous clauses 13, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a width of one or more of the plurality of arms.

Article 14 the method according to any one of the articles, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a thickness dimension of the appliance.

The method of any of the preceding claims, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising mechanical properties of one or more of the plurality of arms.

Clause 16 is a method according to any of the aspects herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a design of an anchor.

Article 17 the method of any of the articles herein, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a width or a thickness of the anchor.

Article 18 the method of any of the articles, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising a transition temperature of a material in one or more segments of the appliance.

Article 19 the method of any of the articles, wherein determining the configuration of the orthodontic appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the output data comprising the connection locations between the plurality of arms and the anchor.

The method of any of the previous items 20, wherein acquiring OTA data comprises imaging the patient's teeth.

The method of any of the previous clauses 21, wherein acquiring OTA data comprises receiving image data of the patient's teeth.

Article 22 the method according to any of the articles, wherein obtaining FTA data comprises receiving FTA data from one or more remote computing devices.

Article 23 the method of any one of the previous claims, wherein obtaining FTA data comprises manipulating the tooth position from the OTA to a second arrangement, and generating FTA data based on the second arrangement.

Clause 24 is the method according to any of the aspects herein, wherein determining the displacement comprises determining the displacement in six degrees of freedom.

The method of any one of the items 25, wherein determining the displacement comprises determining a longitudinal displacement along at least one of an occlusal gingival axis, a bucco-lingual axis, or a mesial-distal central axis.

Article 26 the method according to any one of the previous claims, wherein determining the displacement comprises determining a rotational displacement along at least one of an occlusal gingival axis, a bucco-lingual axis, or a mesial-distal central axis.

Article 27 the method according to any one of the articles, wherein determining the displacement comprises determining a translation of each of the patient's teeth.

Article 28 the method of any one of the previous claims, wherein determining the displacement comprises determining a rotation of each of the patient's teeth.

The method of any one of the articles 29, further comprising determining a force required to achieve the determined displacement for each of the patient's teeth.

The method of any one of the article 30, further comprising determining a torque required to achieve the determined displacement for each of the patient's teeth.

Clause 31 of the method according to any of the herein, wherein each arm is configured to be coupled to a different one of the patient's teeth.

Article 32 the method according to any of the articles, wherein determining the configuration of the orthodontic appliance comprises selecting an arm configuration for each of the patient's teeth, the arm configured for applying a desired force and/or torque to achieve a determined displacement of the respective tooth.

The method of any of the preceding clauses 33, wherein determining the configuration of the orthodontic appliance comprises determining a configuration of one of a plurality of arms configured to effect a determined displacement of a respective tooth.

Clause 34 is directed to a method according to any of the aspects herein, wherein determining a configuration of an orthodontic appliance comprises selecting an arm design from a library of predetermined arm designs.

Clause 35 is directed to a method according to any of the aspects herein, wherein determining a configuration of the orthodontic appliance includes designing a biasing portion of each arm to achieve a determined displacement of the respective tooth.

Clause 36 of the methods according to any of the herein, further comprising determining a force and moment to achieve the determined displacement of each tooth, and selecting one arm to achieve the determined force and moment.

Article 37 is a method according to any of the present articles, further comprising obtaining position data corresponding to a position of a patient's tooth in the OTA, indicating a position at which a plurality of securing members (securing members) are configured to attach to the patient's tooth.

The method of making an orthodontic appliance of clause 38, comprising:

acquiring three-dimensional (3D) shape data of a orthotic;

generating plane shape data based on the 3D shape data;

forming a substantially planar member based on the planar shape data;

manipulating the member into a 3D configuration; and

the member in the 3D configuration is shape-fixed.

Article 39 the method according to any one of the articles, wherein the 3D shape data corresponds to a Final Tooth Arrangement (FTA).

Clause 40 is the method according to any of the aspects herein, wherein the 3D shape data corresponds at least in part to a surface of a heat treatment fixture (texture).

Article 41 is a method according to any of the articles, wherein the 3D shape data defines an anchor and a plurality of arms extending away from the anchor, each arm configured to be coupled to at least one tooth of the patient.

Clause 42 of the method according to any of the present disclosure, wherein the planar shape data comprises elongated shape data.

Clause 43 is the method according to any of the herein, wherein the plane shape data comprises 2D shape data.

Clause 44 is the method according to any of the aspects herein, wherein generating the planar shape data comprises flattening (flattening)3D shape data.

Clause 45 is the method according to any of the aspects herein, wherein generating the plane shape data comprises converting the 3D shape data to plane shape data.

Clause 46 is directed to a method according to any of the aspects herein, wherein forming the substantially planar member includes cutting the substantially planar member from a sheet of material (sheet) based at least in part on the plan shape data.

Clause 47 is directed to the method according to any of the aspects herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a sheet of metal.

Clause 48 is directed to a method according to any of the aspects herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a Nitinol (Nitinol) sheet.

Clause 49 is directed to the method according to any of the aspects herein, wherein forming the substantially planar member comprises cutting the member from a sheet of material having a thickness between about 0.1mm and about 1.0mm, between about 0.2mm and about 0.9mm, between about 0.3mm and about 0.8mm, between about 0.4mm and about 0.7mm, or about 0.5 mm.

The 50 th strip according to the method of any one of the present articles, wherein forming a substantially planar member comprises cutting the member from a sheet of material having a thickness of less than about 1.5mm, less than about 1.4mm, less than about 1.3mm, less than about 1.2mm, less than about 1.1mm, less than about 1.0mm, less than about 0.9mm, less than about 0.8mm, less than about 0.7mm, less than about 0.6mm, less than about 0.5mm, less than about 0.4mm, less than about 0.3mm, less than about 0.2mm, or less than about 0.1 mm.

Clause 51 is directed to a method according to any of the aspects herein, wherein forming the substantially planar member comprises cutting the substantially planar member from a sheet of material by at least one of laser cutting (laser cutting), milling (milling), wire electrical discharge machining (wire electrical discharge machining), water jet (water jet), punching (stamping), or stamping (stamping).

Clause 52 is the method according to any of the preceding claims, wherein the manipulation member comprises a curved member.

Clause 53 is a method according to any of the preceding claims, wherein manipulating the member comprises coupling the member to a heat treatment fixture.

Clause 54 is a method according to any of the preceding claims, wherein manipulating the component comprises conforming the component to a surface of a heat treatment fixture.

Clause 55 the method according to clause 53 or 54 herein, wherein the heat treatment fixture comprises a surface geometry corresponding to the 3D configuration.

Article 56 the method of any one of items 53 to 55 herein, further comprising fastening the member to a heat treatment fixture.

Clause 57 the method according to clause 56 herein, wherein the fastening comprises securing the member to the heat treatment fixture by one or more elongated flexible (flex) elements.

Clause 58 is the method according to any of the above, wherein the shape-fixing the component comprises heat-setting the component.

Clause 59 is the method according to any of the herein, wherein shape setting the shape of the member comprises heating the member to at least 200 degrees celsius.

Article 60 the method of any one of articles 58 or 59 herein, further comprising cooling the component by liquid quenching or air cooling after heating the component.

Article 61 the method of any one of articles 58 to 60 herein, further comprising removing the member from the heat treatment fixture.

Clause 62 the method according to clause 61 herein, further comprising polishing, electropolishing, electroplating, coating, ultrasonically cleaning, or sterilizing the component after removing the component from the heat treatment fixture.

Clause 63 is a method according to any of the articles herein, further comprising selectively thinning (tying) at least a portion of the planar member.

Article 64 the method of article 63, wherein the selective thinning comprises one or more of: grinding, etching or machining.

Clause 65 is a method according to any of the aspects herein, further comprising selectively thickening at least a portion of the planar member.

Clause 66 the method according to clause 65 herein, wherein the selective thickening comprises 3D printing, electroplating or film deposition on at least a portion of the planar member.

Article 67 a method of making a heat treatment fixture for an orthodontic appliance, the method comprising:

obtaining Final Tooth Arrangement (FTA) data corresponding to a desired tooth arrangement;

manipulating the FTA data to obtain fixture data defining a geometry of the heat treatment fixture; and

a heat treatment fixture is fabricated based at least in part on the fixture data.

Article 68 the method according to any of the present articles, wherein the FTA data comprises a fixation member position at which a fixation member is configured to be placed on each tooth.

Clause 69 is the method of clause 68, wherein the securing member is configured to mate with an arm of the orthodontic appliance.

Clause 70 the method according to any of the present articles, wherein the FTA data comprises data characterizing the gums, wherein manipulating the modified FTA data comprises changing the size and/or position of the gums.

Clause 71 is the method of clause 70, wherein the altering the size and/or position of the gingiva comprises expanding the gingiva.

Clause 72 the method of clause 70 or clause 71, wherein the varying the size of the gingiva comprises expanding the gingiva at least in a lingual direction.

Clause 73 the method of any one of clauses 70 to 72, wherein the changing the size or position of the gingiva comprises expanding the gingiva by a distance of: less than about 1.5mm, less than about 1.4mm, less than about 1.3mm, less than about 1.2mm, less than about 1.1mm, less than about 1.0mm, less than about 0.9mm, less than about 0.8mm, less than about 0.7mm, less than about 0.6mm, less than about 0.5mm, less than about 0.4mm, less than about 0.3mm, less than about 0.2mm, or less than about 0.1 mm.

Clause 74 the method according to any of the present articles, wherein manipulating the FTA data comprises removing one or more teeth from the FTA data.

Clause 75 is a method according to any of the aspects herein, wherein manipulating the FTA data comprises adding a stiffening element.

Article 76 the method according to any of the preceding claims, wherein manipulating the FTA data comprises adding a crossbar (crossbar).

Article 77 the method according to any of the claims, wherein manipulating the FTA data changes the geometry of the heat treatment fixture to increase its stiffness.

Article 78 a method according to any one of the preceding claims, wherein the FTA data comprises data characterizing the fixation member, and wherein manipulating the FTA data comprises modifying the fixation member data to change a shape of the fixation member.

Clause 79 is directed to a method according to any of the articles herein, wherein the FTA data comprises a fixation member configured to mate with an orthodontic appliance arm, wherein modifying the FTA data comprises changing a shape of the fixation member.

The method of clause 80 according to clause 79, wherein changing the shape of the fixation member comprises shaping the fixation member to mate with an arm of an orthodontic appliance and receiving an elongated fastener for coupling the appliance to a heat treatment fixture.

Clause 81 is directed to a method according to any of the preceding claims, wherein fabricating the heat treatment fixture comprises forming the heat treatment fixture of a metal or ceramic material.

Clause 82 is a method according to any of the articles herein, wherein manufacturing the heat treatment fixture includes forming the heat treatment fixture using one or more of molding, 3D printing, or casting.

Article 83 is a method according to any of the articles herein, further comprising coupling the orthodontic appliance to a heat treatment fixture and heating the appliance and the heat treatment fixture.

Article 84 the method of article 83, wherein heating the aligner and the heat treatment fixture comprises heating to at least 200 degrees celsius.

Article 85 the method of article 84, further comprising cooling the aligner and the heat treatment fixture after heating by liquid quenching or air cooling.

The method of any of clauses 83-85, wherein coupling the orthodontic appliance to the heat treatment jig comprises wrapping one or more elongate fasteners around the orthodontic appliance and the heat treatment jig.

Article 87 a computer-readable medium comprising instructions configured to store instructions that, when executed by one or more processors, cause the one or more processors to perform the method of any one of the articles herein.

Article 88 a device, comprising:

one or more processors; and

a computer-readable medium comprising instructions configured to be stored, which when executed by one or more processors, cause the one or more processors to perform the method of any one of the articles herein.

An 89 th orthodontic appliance made according to the method of any one of the articles herein.

The 90 th heat treatment fixture, manufactured according to the method of any one of the preceding claims.

Drawings

Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Emphasis instead being placed upon clearly illustrating the principles of the present disclosure.

Fig. 1A illustrates a schematic view of an orthodontic appliance configured in accordance with the present technology installed in a patient's mouth in proximity to a patient's dentition (dentition).

FIG. 1B is a schematic illustration of connection configuration options configured in accordance with embodiments of the present technology.

Figure 1C is a schematic illustration of a portion of an appliance configured in accordance with embodiments of the present technology.

Fig. 2A and 2B are front views of appliances configured in accordance with several embodiments of the present technology, installed in the upper and lower jaws of a patient's mouth with the patient's teeth in an original tooth arrangement and a final tooth arrangement, respectively.

Fig. 2C is a graph showing stress-strain curves for nitinol and steel.

Fig. 3 depicts an example method of manufacturing an orthodontic appliance in accordance with the present technology.

Fig. 4 is a schematic block diagram of a system for manufacturing an orthodontic appliance in accordance with the present technique.

Fig. 5 is a flow chart of a process for designing an orthodontic appliance according to the present technology.

Fig. 6 illustrates scanning a patient's teeth to obtain raw dental alignment data.

Fig. 7 shows an example of a digital model of a patient's teeth and gums in an original tooth arrangement.

Fig. 8 shows an example of a digital model of the patient's teeth and gums in the final tooth arrangement.

Fig. 9 shows an example of a digital model of the fixing member.

Fig. 10 shows an example of a digital model of a patient's teeth and gums and a plurality of fixation members in an original tooth arrangement.

Fig. 11 shows an example of a digital model of a patient's teeth and gums and a plurality of fixation members in a final tooth arrangement.

Fig. 12 shows an example of a digital model of a heat treatment jig.

Figure 13 illustrates an example of a digital model of a three-dimensional appliance template based on a heat treatment fixture model.

Figure 14 illustrates an example of a digital model of a substantially planar appliance template.

Figure 15 illustrates an example of a digital model of an appliance having a substantially planar unique arm geometry based on a determined displacement of each tooth.

Fig. 16 illustrates a perspective view of an orthodontic appliance in accordance with an embodiment of the present technology.

Figure 17 illustrates a perspective view of a heat treatment fixture for an aligner according to the present technology.

Fig. 18 is a perspective view of an orthodontic appliance secured to a heat treatment fixture in accordance with the present technique.

Detailed Description

The present technology relates generally to orthodontic appliances and related systems configured for repositioning one or more teeth of a patient. In particular embodiments, the present technology relates to devices, systems, and methods for attaching or securing orthodontic appliances to teeth, and related methods for designing and manufacturing such appliances. Specific details of several embodiments of the technique are described below with reference to fig. 1A-18.

I. Definition of

The terms used herein to provide anatomical directions or orientations are intended to encompass different orientations of the appliance installed in a patient's mouth, regardless of whether the structure is shown installed in the mouth in the drawings. For example, "mesial" refers to along a patient's curved dental arch (dent arch) in a direction toward the midline of the patient's face; "distal" refers to along the patient's curved arch in a direction away from the midline of the patient's face; "occlusal side" means in a direction toward the chewing surface of a patient's teeth; "gingival side" means in a direction toward the patient's gums or gingiva; "facial (facial)" means in a direction toward the patient's lips or cheeks (which may be used interchangeably herein with "buccal" and "labial"); "lingual" means in a direction toward the patient's tongue.

As used herein, the terms "proximal" and "distal" refer to locations that are closer and farther, respectively, from a given reference point. In many cases, the reference point is a connector, such as an anchor, "proximal" and "distal" refer to locations closer to and further from the reference connector, respectively, along a line passing through the centroid of a cross-section of a portion of the orthosis branching from the reference connector.

As used herein, the terms "general," "basic," "about," and the like are used as approximate terms and not as terms of degree, to account for inherent variations in measured or calculated values that would be recognized by one of ordinary skill in the art.

As used herein, the term "operator" refers to a clinician, practitioner, technician, or any person or machine that designs and/or manufactures an orthodontic appliance or portion thereof and/or assists in the design and/or manufacture of an appliance or portion thereof, and/or any person or machine associated with installing an appliance in a patient's mouth and/or performing any subsequent treatment on a patient associated with the appliance.

As used herein, the term "force" refers to the magnitude and/or direction of a force, torque, or combination thereof.

Overview of orthodontic appliances of the prior art

Fig. 1A is a schematic view of an orthodontic appliance 100 (or "appliance 100") configured in accordance with embodiments of the present technique, shown positioned in a patient's mouth in the vicinity of the patient's teeth. Figure 1B is an enlarged view of a portion of the orthotic 100. The appliance 100 is configured to be installed within a patient's mouth in order to exert a force on one or more teeth to reposition all or some of the teeth. In some cases, the appliance 100 may additionally or alternatively be configured to maintain the position of one or more teeth. As shown in fig. 1A and 1B, the appliance 100 may include a deformable member including one or more attachment portions 140 (each schematically represented by a box) each configured to be secured directly or indirectly to a tooth surface by a securing member 160. The orthotic 100 may also include one or more connectors 102 (also shown schematically), each extending directly between the attachment portions 140 ("first connectors 104"), between the attachment portions 140 and one or more other connectors 102 ("second connectors 106"), or between two or more other connectors 102 ("third connectors 108"). Only two attachment portions 140 and two connectors 102 are labeled in fig. 1A for ease of illustration. As described herein, the number, configuration, and location of the connectors 102 and attachment portions 140 may be selected to provide a desired force on one or more teeth when the appliance 100 is installed.

The attachment portion 140 may be configured to be removably coupled to a securing member 160 that is bonded, adhered, or otherwise secured to a surface of one of the teeth to be moved. In some embodiments, one or more attachment portions 140 may be directly bonded, adhered, or otherwise secured to the respective teeth without a securing member or other connection interface (interface) at the teeth. The different attachment portions 140 of a given orthotic 100 may have the same or different shapes, the same or different sizes, and/or the same or different configurations. The attachment portion 140 may include any of the attachment portions, bracket connectors, and/or male connector elements disclosed in U.S. patent publication No. 2017/0156823a1, which is incorporated by reference herein in its entirety.

The appliance 100 may include any number of attachment portions 140 suitable for securely attaching the appliance 100 to one or more teeth of a patient to achieve a desired movement. In some examples, multiple attachment portions 140 may be attached to a single tooth. The appliance 100 may include an attachment portion for each tooth, fewer attachment portions than teeth, or more attachment portions 140 than teeth. In these and other embodiments, one or more attachment portions 140 of the orthotic 100 may be configured to couple to one, two, three, four, five, or more connectors 102.

As previously described, the connector 102 may include one or more first connectors 104 extending directly between the attachment portions 140. The one or more first connectors 104 may extend along a substantially mesial-distal (mediodistal) dimension when the appliance 100 is installed in the mouth of a patient. In these and other embodiments, the appliance 100 may include one or more first connectors 104 that extend along a generally occlusal gingival and/or buccolingual (buccolingual) dimension when the appliance 100 is installed in the patient's mouth. In some embodiments, the orthotic 100 does not include any first connectors 104.

Additionally or alternatively, the connector 102 may include one or more second connectors 106 extending between the one or more attachment portions 140 and the one or more connectors 102. The one or more second connectors 106 can extend along a dimension that substantially bites the gums when the appliance 100 is installed in the patient's mouth. In these and other embodiments, the appliance 100 may include one or more second connectors 106 that extend along a generally mesial-distal and/or bucco-lingual dimension when the appliance 100 is installed in the patient's mouth. In some embodiments, the orthotic 100 does not include any second connectors 106. In such an embodiment, the orthotic 100 would only include the first connector 104 extending between the attachment portions 140. The second connector 106 and the attachment portion 140 attached thereto may include an "arm (arm)" as used herein (such as the arm 130 in fig. 1A and 1B). In some embodiments, multiple second connectors 106 may extend from the same location along the orthotic 100 to the same attachment portion 140. In such a case, the plurality of second connectors 106 and the attachment portion 140 together comprise an "arm" as used in this application. Using two or more connectors to connect two points on the orthotic 100 enables a greater force to be applied (relative to connecting the same points using a single connector) without increasing the strain on the single connector. This configuration is particularly beneficial in view of the spatial constraints of fixed displacement therapy herein.

Additionally or alternatively, the connector 102 may include one or more third connectors 108 that extend between two or more other connectors 102. The one or more third connectors 108 may extend along a generally mesial-distal dimension when the appliance 100 is installed in the mouth of a patient. In these and other embodiments, the appliance 100 may include one or more third connectors 108 that extend along a dimension that generally bites the gingiva and/or bucco-lingual when the appliance 100 is installed in the patient's mouth. In some embodiments, the orthotic 100 does not include any third connectors 108. One, some, or all of the third connectors 108 may be positioned gingivally with respect to one, some, or all of the first connectors 104. In some embodiments, the appliance 100 includes a single third connector 108 that extends along at least two adjacent teeth and provides a common connection for two or more second connectors 106. In several embodiments, the appliance 100 includes a plurality of discrete third connectors 108, each of which extends along at least two adjacent teeth.

As shown in fig. 1A, in some embodiments, the appliance 100 may be configured such that all or a portion of one, some, or all of the connectors 102 are disposed near the patient's gums when the appliance 100 is installed in the patient's mouth. For example, the one or more third connectors 108 may be configured such that all or a portion of the one or more third connectors 108 are located below the patient's gum line and near the gum but spaced apart from the gum. In many cases, it may be beneficial to provide a small gap (e.g., 0.5mm or less) between the third connector 108 and the patient's gums because contact between the third connector 108 (or any portion of the appliance 100) and the gums can cause irritation and patient discomfort. In some embodiments, all or a portion of the third connector 108 is configured to be in direct contact with the gums when the appliance 100 is disposed in the patient's mouth. Additionally or alternatively, all or a portion of one or more of the first connector 104 and/or the second connector 106 may be configured to be disposed proximate to the gums.

According to some embodiments, one or more connectors 102 may extend between an attachment portion 140 or a connector 102 and a joint including (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one attachment portion 140 and at least one connector 102. According to some embodiments, one or more connectors 102 may extend between a first joint that includes (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one connecting member and at least one connector 102, and a second joint that includes (a) two or more connectors 102, (b) two or more attachment portions 140, or (c) at least one attachment portion 140 and at least one connector 102. An example of a connector 102 extending between (a) the joint between the second connector 106 and the third connector 108 and (B) the joint between the second connector 106 and the attachment portion 140 is schematically depicted in fig. 1B and is labeled 109 in this figure.

Each connector 102 may be designed to have a desired stiffness such that a single connector 102 or combination of connectors 102 exerts a desired force on one or more teeth. In many cases, the force exerted by a given connector 102 may be controlled by Hooke's Law or F ═ k × x, where F is the restoring force exerted by the connector 102, k is the stiffness coefficient of the connector 102, and x is the displacement. In the most basic example, if there is no connector 102 between two points on the orthotic 100, the stiffness coefficient along the path is zero and no force is applied. In this example, each connector 102 of the present technology may have a different non-zero stiffness coefficient. For example, one or more connectors 102 may be rigid (i.e., the stiffness coefficient is infinite) such that the connector 102 does not flex or bend between its two endpoints. In some embodiments, one or more connectors 102 may be "flexible" (i.e., a non-zero and positive stiffness coefficient) such that the connector 102 may deform to exert (or absorb) a force on the associated one or more teeth or other connectors 102.

In some embodiments, it may be beneficial to include one or more rigid connectors between two or more teeth. The rigid connector 102 is sometimes referred to herein as a "rigid rod" or "anchor". Each rigid connector 102 may be sufficiently rigid to hold and maintain its shape and resist bending. The rigidity of the connector 102 may be achieved by selecting a particular shape, width, length, thickness, and/or material. For example, a connector 102 configured to be relatively rigid may be used when a tooth to be connected to the connector 102 or arm will not move (or move a limited amount) and may be used for anchoring (anchorage). For example, molar teeth provides good anchoring because the roots of molars are larger than most teeth and therefore require more force to move. In addition, anchoring one or more portions of the appliance 100 to multiple teeth may be more secure than anchoring to a single tooth. As another example, a rigid connection may be required when moving a set of teeth relative to one or more other teeth. For example, consider a patient having five teeth separated from one tooth by a gap, and the treatment plan is to close the gap. The best treatment is usually to move one tooth toward five teeth, not the opposite. In such a case, it may be beneficial to provide one or more rigid connectors between the five teeth. For all of the above reasons and many others, the orthotic 100 may include one or more rigid first connectors 104, one or more rigid second connectors 106, and/or one or more rigid third connectors 108.

In these and other embodiments, the orthotic 100 may include one or more flexible first connectors 104, one or more flexible second connectors 106, and/or one or more flexible third connectors 108. Each flexible connector 102 may have a particular shape, width, thickness, length, material, and/or other parameters to provide a desired degree of flexibility. In accordance with some embodiments of the present technique, the stiffness of a given connector 102 may be adjusted by incorporating one or more resilient flexible biasing (biasing) portions 150. As schematically shown in fig. 1B, one, some or all of the connectors 102 may include one or more biasing portions 150, such as springs, each configured for applying a customized force specific to the tooth to which it is attached.

As shown in the schematic illustration of fig. 1C, the biasing portion 150 may extend along all or a portion of the longitudinal axis L1 of the respective connector 102 (only the longitudinal axis L1 for the second connector 106 and the longitudinal axis L2 for the third connector 108 are labeled in fig. 1C). The direction and magnitude of the forces and torques exerted by the biasing portion 150 on the tooth depend at least in part on the shape, width, thickness, length, material, shape fixation conditions, and other parameters of the biasing portion 150. Accordingly, one or more aspects of the biasing portion 150 (including the aforementioned parameters) may be varied such that the corresponding arm 130, connector 102, and/or biasing portion 150 produces the desired tooth movement when the appliance 100 is installed in the patient's mouth. Each arm 130 and/or biasing portion 150 may be designed to move one or more teeth in one, two, or all three translational directions (i.e., mesio-distal, buccolingual, and occlusal) and/or in one, two, or all three rotational directions (i.e., buccolingual root torque), mesio-distal angle (medial adjustment), and mesio-distal rotation (medial out-in rotation).

The biasing portion 150 of the present technique can have any length, width, shape, and/or size sufficient to move the corresponding tooth to the desired position. In some embodiments, one, some, or all of the connectors 102 may have one or more inflection points along the respective biasing portion 150. The connector 102 and/or the biasing portion 150 may have a serpentine configuration such that the connector 102 and/or the biasing portion 150 is folded back upon itself at least one or more times before extending toward the attachment portion 140. For example, in some embodiments, the second connector 106 is doubled back on itself along the biasing portion 150, thereby forming a first concave region and a second concave region facing generally different directions relative to each other. Open loops or overlapping portions of the connector 102 corresponding to the biasing portion 150 may be disposed on either side of a plane P (fig. 1C) bisecting the overall width W (fig. 1C) of the arm 130 and/or the connector 102, such that additional length of the arm 130 and/or the connector 102 is received by a central (medial) and/or distal (digital) space of the arm 130 and/or the connector 102. This allows the arm 130 and/or connector 102 to have a longer length (as compared to a linear arm) to accommodate greater tooth movement despite the limited space in the occlusal-gingival or vertical dimension between any associated third connector 108 and the location where the arm 130 attaches to the tooth.

It should be understood that the biasing portion 150 may have other shapes or configurations. For example, in some embodiments, the connector 102 and/or the biasing portion 150 may include one or more linear regions that meander (zig-zag) toward the attachment portion 140. One, some or all of the connectors 102 and/or the biasing portion 150 may have only linear segments or regions, or may have a combination of curved and linear regions. In some embodiments, one, some, or all of the connectors 102 and/or the biasing portion 150 do not include any curved portions.

According to some examples, a single connector 102 may have multiple biasing portions 150 in series along a longitudinal axis of the respective connector 102. In some embodiments, the plurality of connectors 102 may extend between two points along the same or different paths. In these embodiments, the different connectors 102 may have the same stiffness or different stiffnesses.

In those embodiments where the orthotic 100 has two or more connectors 102 with biasing portions 150, some, none, or all of the connectors 102 may have the same or different lengths, the same or different widths, the same or different thicknesses, the same or different shapes, and/or may be made of the same or different materials, among other characteristics. In some embodiments, less than all of the connectors 102 have biasing portions 150. For example, the connector 102 without the biasing portion 150 may include one or more rigid connections between the rigid third connector 108 and the attachment portion 140. In some embodiments, none of the connectors 102 of the orthotic 100 have a biasing portion 150.

According to some embodiments, for example, as schematically depicted in fig. 1A, the orthosis 100 can include a single, continuous, substantially rigid third connector (referred to as "anchor 120") and a plurality of flexible arms 130 extending away from the anchor 120. When the appliance 100 is installed in a patient's mouth, each arm 130 may be connected to a different tooth to be moved and exert a particular force on its respective tooth, thereby allowing the operator to move each tooth independently. This configuration provides a significant improvement over conventional braces in which all teeth are connected by a single archwire, and thus movement of one tooth may result in unintended movement of one or more nearby teeth. As discussed in more detail herein, the independent and customized tooth movement by the appliances of the present technology allows an operator to more efficiently move teeth from an original tooth arrangement ("OTA") to a final tooth arrangement ("FTA"), thereby avoiding periodic adjustments, reducing the number of revisions, and reducing or eliminating patient discomfort, as well as reducing the overall treatment time (i.e., the length of time the appliance is installed in a patient's mouth) by at least 50% relative to the overall treatment time of a conventional mouthpiece.

Anchor 120 may comprise any structure having any shape and size configured to fit comfortably within a patient's mouth and provide a common support for one or more arms 130. In many embodiments, for example, as shown in fig. 1B, the anchor 120 is disposed near the patient's gums when the appliance 100 is installed in the patient's mouth. For example, the appliance may be designed such that, when installed in a patient's mouth, all or a portion of the anchor 120 is positioned below the patient's gum line, near but spaced from the gum. In many cases, it may be beneficial to provide a small gap (e.g., 0.5mm or less) between the anchor 120 (or any portion of the appliance 100) and the patient's gums because the contact between the anchor 120 and the gums may cause irritation and patient discomfort. In some embodiments, all or a portion of the anchor 120 is configured to contact the gums when the appliance 100 is disposed in the patient's mouth.

Anchors 120 may be substantially more rigid than arms 130, such that when a force is applied to their respective teeth, the equal and opposite force experienced by each arm 130 is offset by the rigidity of anchor 120 and the force applied by the other arms 130 and does not have a significant effect on the force on the other teeth. Thus, anchors 120 effectively isolate the force experienced by each arm 130 from the remaining arms 130, thereby enabling independent tooth movement.

According to some embodiments, for example, as schematically shown in fig. 1A and 1B, anchor 120 comprises an elongated member having a longitudinal axis L2 (see fig. 1C) and forming an arch configured to extend along the chin of the patient when orthosis 100 is installed. In these and other embodiments, anchors 120 can be shaped and sized to span two or more teeth of a patient when positioned in the patient's mouth. In some examples, anchor 120 comprises a rigid linear rod, or may comprise a structure having both linear and curved segments. In these and other embodiments, anchor 120 can extend laterally across all or a portion of the patient's mouth (e.g., across all or a portion of the upper jaw, across all or a portion of the lower jaw, etc.) and/or in a generally anterior-posterior (anti-spatial) direction. Further, the orthotic 100 may comprise a single anchor or multiple anchors. For example, the orthotic 100 may comprise a plurality of discrete, spaced apart anchors, each having two or more arms 130 extending therefrom. In these and other embodiments, the orthotic 100 may comprise one or more other connectors extending between adjacent arms 130.

Any and all of the features discussed above with respect to anchor 120 may be applicable to any of the third connectors 108 disclosed herein.

As shown in fig. 1B, each arm 130 may extend between a proximal or first end portion 130a and a distal or second end portion 130B, and may have a longitudinal axis L extending between the first end portion 130a and the second end portion 130B. First end portions 130a of one, some, or all of arms 130 may be disposed at anchor 120. In some embodiments, one, some, or all of arms 130 are integrally formed with anchor 120 such that first end portions 130a of the arms are continuous with anchor 120. Arms 130 may extend from anchor 120 at intervals along longitudinal axis L2 of anchor 120, as shown in fig. 1A. In some embodiments, arms 130 can be spaced apart from each other at uniform intervals along longitudinal axis L2 of anchor 120, or at non-uniform intervals from each other.

One, some, or all of the arms 130 may include an attachment portion 140 at or near the second end portion 130 b. In some embodiments, for example, as shown in fig. 1A-1C, one or more arms 130 are cantilevered from anchor 120 such that second end portions 130b of cantilevered arms 130 have free distal end portions 130 b. In these and other embodiments, the distal end of the attachment portion 140 may coincide with the distal end of the arm 130. The attachment portions 140 may be configured to removably couple the respective arms 130 to a fixation member (e.g., bracket) that is bonded, adhered, or otherwise secured to a surface of one of the teeth to be moved. In some embodiments, the attachment portions 140 may be directly bonded, adhered, or otherwise secured to the respective teeth without a securing member or other connecting interface at the teeth.

Still referring to fig. 1A and 1B, one, some, or all of the arms 130 may include one or more resiliently flexible biasing portions 150, such as springs, each configured to apply a customized force, torque, or combination of force and torque specific to the tooth to which it is attached. Biasing portions 150 may extend between anchor 120 and attachment portion 140 along all or a portion of longitudinal axis L1 of respective arm 130. The direction and magnitude of the forces and torques exerted by the biasing portion 150 on the tooth depend at least in part on the shape, width, thickness, length, material, shape fixation conditions, and other parameters of the biasing portion 150. Accordingly, one or more aspects of the arm 130 and/or the biasing portion 150 (including the aforementioned parameters) may be varied such that the arm 130 and/or the biasing portion 150 produce a desired tooth movement when the appliance 100 is installed in the mouth of a patient. Each arm 130 and/or biasing portion 150 can be designed to move one or more teeth in one, two, or all three translational directions (i.e., mesio-distal, buccolingual, and occlusal) and/or in one, two, or all three rotational directions (i.e., buccolingual root torque, mesio-distal angle, and mesio-distal internal rotation).

The biasing portion 150 of the present technique can have any length, width, shape, and/or size sufficient to move the corresponding tooth toward the desired FTA. In some embodiments, one, some, or all of the arms 130 may have one or more inflection points along the respective biasing portion 150. The arm 130 and/or the biasing portion 150 may have a serpentine configuration such that the arm 130 and/or the biasing portion 150 is folded back upon itself at least one or more times before extending toward the attachment portion 140. In FIG. 1B, the arm 130 is folded back on itself twice along the biasing portion 150, thereby forming a first concave region and a second concave region facing generally different directions relative to each other. Open loops or overlapping portions of the arm 130 corresponding to the biasing portion 150 may be disposed on either side of a plane P bisecting the overall width W of the arm 130 such that the additional length of the arm 130 is received by the central and/or distal space of the arm 130. This allows the arm 130 to have a longer length (compared to a linear arm) to accommodate greater tooth movement despite the limited space in the occlusal-gingival or vertical dimension between the anchor 120 and the location where the arm 130 attaches to the tooth.

It should be understood that the biasing portion 150 may have other shapes or configurations. For example, in some embodiments, the arm 130 and/or the biasing portion 150 may include one or more linear regions that meander toward the attachment portion 140. One, some or all of the arms 130 and/or the biasing portion 150 may have only linear segments or regions, or may have a combination of curved and linear regions. In some embodiments, one, some, or all of the arms 130 and/or biasing portions 150 do not include any curved portions.

According to some examples, a single arm 130 may have multiple biasing portions 150. The plurality of biasing portions 150 may be connected in series along the longitudinal axis L1 of the respective arm 120. In some embodiments, the plurality of arms 130 may extend in parallel between two points along the same path or different paths. In these embodiments, different arms 130 may have the same stiffness or different stiffnesses.

In embodiments where the orthotic 100 has two or more arms 130 with biasing portions 150, some, none, or all of the arms 130 may have the same or different lengths, the same or different widths, the same or different thicknesses, the same or different shapes, and/or may be made of the same or different materials, among other characteristics. In some embodiments, less than all of the arms 130 have biasing portions 150. For example, arms 130 without biasing portions 150 may include one or more rigid connections between anchors 120 and attachment portions 140. In some embodiments, none of the arms 130 of the orthotic 100 have a biasing portion 150.

The appliances of the present technology may include any number of arms 130 suitable for repositioning the teeth of a patient while taking into account patient comfort. Unless specifically defined in the specification as a particular number of arms, the orthotic of the present technology may include a single arm, two arms, three arms, five arms, ten arms, sixteen arms, or the like. In some examples, one, some, or all of the arms 130 of the appliance may be configured to individually connect to more than one tooth (i.e., a single arm 130 may be configured to couple to two teeth simultaneously). In these and other embodiments, the appliance 100 may include two or more arms 130 configured to be simultaneously connected to the same tooth.

Any portion of the present technology orthotic may include a biasing portion 150. For example, in some embodiments, portions thereof (e.g., anchors, arms, biasing portions, attachment portions, linkages, etc.) can comprise one or more superelastic materials.

Additional details regarding the single directional force applied by the biasing portion 150 (or more generally, by the arm 130) are described in U.S. patent publication No. 2017/0156823a1, the disclosure of which is incorporated herein by reference in its entirety.

The orthosis disclosed herein and/or any portion thereof (e.g., anchor, arm, biasing portion, attachment portion, linkage, etc.) may comprise one or more superelastic materials. The orthosis disclosed herein and/or any portion thereof (e.g., anchor, arm, biasing portion, attachment portion, linkage, etc.) may comprise nitinol, stainless steel, beta titanium, cobalt chrome, MP35N, 35N LT, one or more metal alloys, one or more polymers, one or more ceramics, and/or combinations thereof.

Fig. 2A and 2B are front views of the appliance 100 installed on both the upper and lower arches of a patient's mouth M, with the arms 130 coupled to securing members 160 attached to the lingual surfaces of the teeth. It should be appreciated that the appliances 100 of one or both of the upper and lower dental arches may be located near the buccal side of the patient's teeth, and the securing members 160 and/or arms 130 may alternatively be coupled to the buccal surface of the teeth.

Fig. 2A shows the tooth in an OTA with the arm 130 in a deformed or loaded state, and fig. 2B shows the tooth in an FTA with the arm 130 in a substantially unloaded state. When the tooth is in the OTA, when the arm 130 is initially secured to the securing member 160, the arm 130 is forced to assume a different shape or path than its "designed" configuration. Due to the inherent memory of the resilient biasing portion 150, the arms 130 exert a continuous corrective force on the teeth to move the teeth toward the FTA, which is the position of the biasing portion 150 in its designed or unloaded configuration. Thus, an appliance using the present techniques may accomplish tooth repositioning in a single step using a single appliance. In addition to achieving less revisions and shorter treatment times than braces, the appliances of the present technology greatly reduce or eliminate the pain experienced by the patient due to tooth movement. With conventional braces, each time the orthodontist makes an adjustment (such as installing a new archwire, bending an existing archwire, repositioning brackets, etc.), the affected teeth are subjected to significant forces, which can be very painful to the patient. Over time, the applied force gradually weakens until a new archwire is eventually required. However, the appliances of the present technology continuously apply a force on the teeth that creates motion when the appliance is installed, which allows the teeth to move at a slower speed, which is much less painful (if at all) to the patient. Even though the appliances disclosed herein apply a low and less painful force to the teeth, because the force applied is continuous and the teeth can move independently (and therefore more effectively), the appliances of the present technology also reach the FTA faster than traditional braces or aligners, which both require intermediate adjustments.

In many embodiments, the motion-generating force is lower than the force applied by conventional braces. In those embodiments where the appliance comprises a superelastic material, such as nitinol, the superelastic material behaves like a constant force spring over a range of strains, so the applied force does not drop significantly as the teeth move. For example, as shown by the stress-strain curves for nitinol and steel in fig. 2C, the curve for nitinol is relatively flat compared to steel. Thus, the superelastic connectors, biasing portions, and/or arms of the present technology apply substantially the same stress to many different strain levels (e.g., deflections). Thus, as the teeth move during treatment, the force applied to a given tooth remains constant, at least until the teeth are in close proximity or in final alignment. The appliances of the present technology are configured to apply a force just below the pain threshold such that the appliance applies a maximum non-painful force to the tooth (or teeth) at all times during tooth movement. This will result in the most effective (i.e., fastest) tooth movement without pain.

In some embodiments, tooth repositioning may involve multiple steps performed in steps using multiple appliances. Embodiments involving multiple steps (or multiple appliances, or both) may include one or more Intermediate Tooth Arrangements (ITAs) between an Original Tooth Arrangement (OTA) and a desired Final Tooth Arrangement (FTA). Likewise, the appliances disclosed herein may be designed to be installed after the first or subsequently used appliance has moved the teeth from OTA to ITA (or from one ITA to another ITA) and then removed. Accordingly, the appliances of the present technology may be designed to move teeth from an ITA to an FTA (or to another ITA). Additionally or alternatively, the appliance may be designed to move teeth from OTA to ITA, or OTA to FTA without changing the appliance at the ITA.

In some embodiments, the appliances disclosed herein may be configured such that once the appliance is installed on a patient's teeth, the patient cannot remove the appliance. In some embodiments, the appliance is removable by the patient.

Any of the example aligners or portions of the aligners described herein may be made of any suitable material, such as, but not limited to, nitinol, stainless steel, beta titanium, cobalt chrome, or other metal alloys, polymers, or ceramics, and may be made as a single, integrally formed structure, or, alternatively, as a plurality of separately formed components that are joined together into a single structure. However, in specific examples, the rigid rods, bracket connectors, and loop or curved features of the aligners (or portions of the aligners) described in these examples are made by cutting out a two-dimensional (2D) shape of the aligner from a 2D sheet of material and bending the 2D shape into the desired three-dimensional shape of the aligner according to the procedures described in more detail below. Alternatively or additionally, the appliance (or a portion of an appliance) may be formed using any suitable technique, including those described in U.S. patent publication No. 2017/0156823a1, which is incorporated by reference herein in its entirety.

III.Selection method for manufacturing orthodontic appliances and clamps

Fig. 3 illustrates an example process 300 of designing and manufacturing an orthodontic appliance as described elsewhere herein. The particular processes described herein are merely exemplary processes and may be modified as needed to achieve a desired result (e.g., a desired force to be applied by the appliance on each tooth, desired material properties of the appliance, etc.). In various embodiments, the orthodontic appliances may be manufactured using other suitable methods or techniques. Moreover, while various aspects of the methods disclosed herein relate to the order of steps, in various embodiments, the steps may be performed in a different order, two or more steps may be combined, certain steps may be omitted, and additional steps not explicitly discussed may be included in the process as desired.

As described above, in some embodiments, the orthodontic appliances are configured to be coupled to a patient's teeth when the teeth are in an Original Tooth Arrangement (OTA). In this position, the elements of the appliance exert a customized load on the individual teeth, urging them toward the desired Final Tooth Arrangement (FTA). For example, the arms 130 of the appliance 100 may be coupled to teeth and configured to apply a force to urge the teeth in a desired direction toward the FTA. In one example, the arms 130 of the appliance 100 may be configured to apply a pulling force that pushes the teeth lingual along the lingual axis (facial-lingual axis) of the face. By selecting the appropriate size, shape, set of shapes, material properties, and other aspects of the arm 130, a customized load can be applied to each tooth to move each tooth from its OTA toward its FTA. In some embodiments, each arm 130 is configured such that once the tooth to which the arm 130 is coupled reaches its FTA, little or no force is applied to that tooth. In other words, the orthotic 100 may be configured such that the arm 130 is at rest in the FTA state.

As shown in fig. 3, the process 300 may begin at block 302 with acquiring data (e.g., position data) that characterizes a patient's original dental arrangement (OTA). In some embodiments, the operator may obtain a digital representation of the patient OTA, for example using an optical scan, Cone Beam Computed Tomography (CBCT), patient impression scan, or other suitable imaging technique, to obtain position data of the patient's teeth, gums, and optionally other adjacent anatomical structures while the patient's teeth are in the original or pre-treatment state.

The process 300 continues at block 304 with acquiring data (e.g., position data) indicative of an expected or desired Final Tooth Arrangement (FTA) of the patient. The data characterizing the FTA may include coordinates (e.g., X, Y, Z coordinates) for each of the patient's teeth and gums. Additionally or alternatively, such data may include the positioning of each of the patient's teeth relative to the patient's other teeth and/or gums. In some embodiments, the operator may obtain a digital representation of the patient FTA, e.g., an FTA digital model generated using segmentation software (e.g., iROK digital dental Studio) to create a single virtual tooth and gum from OTA data. In some embodiments, a digital model of fixation member 160 may be added to the segmented OTA digital model (e.g., by an operator selecting a location on the lingual surface (or other suitable surface) to place fixation member 160 thereon). The virtual teeth to which the fixation members 160 are attached can be moved from the OTA to a desired final position (e.g., FTA) using suitable software, with or without the digital model of the fixation member.

At block 306, a digital model of the heat treatment fixture may be obtained. In some embodiments, the thermal treatment fixture digital model may correspond to and/or be derived from an FTA digital model. For example, the FTA digital model may be modified in a number of ways (e.g., using a MeshMixer or other suitable modeling software) to present a model suitable for manufacturing a heat treatment fixture. In some embodiments, the FTA digital model may be modified to replace the securing members 160 (which are configured to be coupled to the arms 130 (fig. 2A and 2B) of the orthotic 100) with hook members (which may be configured to facilitate temporary coupling of the heat treatment fixture to the orthotic for shape fixation). Additionally or alternatively, the FTA digital model can be modified to enlarge or thicken the gums, to move one or more teeth, and/or to add structural components to increase stiffness. In some embodiments, the gums may be enlarged or thickened to ensure that portions of the appliance (e.g., anchors) manufactured based in part on the FTA digital model do not engage or contact the patient's gums when the appliance is installed. Thus, the FTA digital model can be modified as described herein to provide a less painful tooth repositioning experience for the patient.

The process 300 continues at block 308 with obtaining a digital model of the appliance. As used herein, the terms "digital model" and "model" mean a virtual representation of an object (object) or set of objects. For example, the term "digital model of an appliance" refers to a virtual representation of the structure and geometry of the appliance, including its various components (e.g., anchors, arms, biasing portions, attachment portions, etc.). In some embodiments, a substantially planar digital model of the orthotic is generated based, at least in part, on the heat treatment fixture digital model (and/or the FTA digital model). According to some examples, a contour or 3D aligner digital model corresponding generally to the FTA may be first generated that conforms to the surface and accessory features of the heat treatment fixture digital model. In some embodiments, the 3D appliance digital model may include a generic arm portion and a fixation member without requiring a particular geometry, size, or other characteristics of the arm selected or defined by a particular patient. The 3D appliance digital model may then be flattened to generate a substantially planar or substantially 2D appliance digital model. In some embodiments, the particular configuration of arms 130 (e.g., the geometry of biasing portion 150, the position along anchors 120 (fig. 1B), etc.) can then be selected so as to apply the required force to urge the corresponding tooth (the tooth to which arms 130 are connected) from its OTA toward its FTA. As previously described, in some embodiments, the arms are configured to be substantially at rest or in a substantially unstressed state when in the FTA. The selected arm configuration may then be replaced or incorporated into the planar orthotic digital model.

At block 310, a heat treatment fixture may be fabricated. For example, the heat treatment fixture may be cast, molded, 3D printed, or otherwise manufactured using a suitable material configured to withstand the heating of the shape fixation on the aligner, using a heat treatment fixture digital model (block 306).

At block 312, an appliance may be manufactured. In some embodiments, manufacturing the appliance includes first manufacturing the appliance in a planar configuration based on a planar appliance digital model. For example, the planar orthotic may be cut from a sheet of metal or other suitable material. In some embodiments, the orthotic is cut from a piece of nitinol or other metal using laser cutting, water jet (water jet), stamping, chemical etching, machining, or other suitable techniques. The material thickness of the aligner may be varied, for example, by electropolishing, etching, grinding, depositing, or otherwise manipulating the material of the aligner to achieve desired material properties.

According to some examples, a planar member (e.g., cut from a sheet of metal) may be bent or otherwise manipulated into a desired arrangement (e.g., substantially corresponding to the FTA) to form a contoured orthotic. In some embodiments, in block 310, the planar orthotic may be bent into place by coupling the planar orthotic to a heat treatment fixture. For example, the arms of the orthotic may be removably connected to the hook members of the heat treatment jig, and optionally, ligatures or other temporary fasteners may be used to secure the arms or other portions of the orthotic to the heat treatment jig. The resulting assembly (i.e., the aligner secured to the heat treatment fixture) may then be heated to secure the aligner shape in a final shape, which may correspond or substantially correspond to the FTA. Thus, the orthotic is configured to be in an unstressed or nearly unstressed state when at the FTA. In operation, the appliance may then be installed in the patient's mouth (e.g., bending or otherwise manipulating the arms of the appliance while in OTA, connecting it to the brackets of the patient's teeth). Due to the fixed shape of the appliance and the geometry of the arms and anchors, the arms urge each tooth away from its OTA and toward the FTA.

Additional details and further process examples of designing and manufacturing the aligner and heat treatment fixture are described below. The particular processes disclosed herein are exemplary and can be modified as needed to achieve a desired result (e.g., a desired force to be applied by the appliance on each tooth, desired material properties of the final appliance, etc.). Moreover, while various aspects of the methods disclosed herein relate to the order of steps, in various embodiments, the steps may be performed in a different order, two or more steps may be combined, certain steps may be omitted, and additional steps not explicitly discussed may be included in the process, as desired.

Several methods disclosed herein may be performed using one or more aspects of the manufacturing system 400 schematically illustrated in fig. 4. System 400 may include an imaging device 402 communicatively coupled to a computing device 404. The imaging device 402 may include any suitable device or collection of devices configured to obtain image data or other digital representations of the patient's teeth, gums, and other dental anatomy. For example, imaging device 402 may include an optical scanning device (e.g., commercially sold by ITERO, 3SHAPE, and other companies), a cone-beam (cone-beam) computer tomography scanner, or any other suitable imaging device. In some embodiments, the imaging device 402 may be any suitable device for obtaining a digital representation (e.g., OTA) of a patient's anatomy, even though such digital representation is not based on and does not produce a graphical representation of the patient's anatomy.

Computing device 404 may be any suitable combination of software and hardware. For example, computing device 404 may include a special purpose computer or data processor that is specially programmed, configured, or constructed to perform one or more of the computer-executable instructions explained in detail herein. Additionally or alternatively, computing device 404 may include a distributed computing environment where tasks or modules are performed by remote processing devices that are linked through a communications network (e.g., a wireless communications network, a wired communications network, a cellular communications network, the internet, a short-range radio network (e.g., via bluetooth)). In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

Computer-executed instructions, data structures, and other data of aspects of the technology may be stored or distributed on computer-readable storage media, including magnetically or optically readable computer disks, as microcode on semiconductor memory, nanotechnology memory, organic or optical memory, or other portable and/or non-transitory data storage media. In some embodiments, the technical aspects may be distributed over the internet or other networks (e.g., bluetooth networks) over a propagating signal on a propagating medium (e.g., electromagnetic waves, sound waves) over a period of time, or may be provided over any analog or digital network (packet-switched, circuit-switched, or other scheme).

The system 400 may also include one or more input devices 406 (e.g., touch screen, keyboard, mouse, microphone, camera, etc.) and one or more output devices 408 (e.g., display, speakers, etc.) coupled to the computing device 404. In operation, a user may provide instructions to computing device 404 and receive output from computing device 404 via input device 406 and output device 408.

As shown in fig. 4, the computing device 404 may be connected to one or more manufacturing systems 410 (including manufacturing machines) for manufacturing the aligners, heat treatment fixtures, and any other components and associated tools as described herein. Computing device 404 may be connected to manufacturing system 410 by any suitable communication connection, including but not limited to a direct electronic connection, a network connection, and the like. Alternatively, the connection may additionally be provided by delivery of a physical, non-transitory storage medium (on which data from computing device 404 is stored) to manufacturing system 410.

Method for designing orthodontic appliances and clamps

Fig. 5 is a flow chart of a process 500 for designing an orthodontic appliance. The process 500 begins at block 502 with obtaining data characterizing an Original Tooth Arrangement (OTA). For example, as shown in fig. 6, OTA data can be obtained by scanning a patient's teeth using an intra-oral optical scanner 600. Such a scanner 600 may be used to scan the upper and lower teeth of a patient to generate a three-dimensional model of each. The scanning may be performed using any suitable technique, such as a dental cone-beam CT scanner, or Magnetic Resonance Imaging (MRI) or similar device or technique. In various examples, OTA data may include data associated with the root and exposed portion, which may be advantageous in designing an appropriate orthodontic appliance. In some examples, OTA data may be obtained using impressions made from the patient's upper and lower jaws (e.g., using polyvinyl siloxane (pviyl siloxane) or any other suitable impression material). The impression may then be scanned to create 3D data, which may include the relationship between the upper and lower jaws (e.g., recording the patient's bite). In the example using an impression, the relationship between teeth in the upper and lower arches (inter-arch relationship) can be obtained by taking a wax bite (wax bite) for the patient's median position. In various embodiments, OTA data can be obtained directly (e.g., by imaging the patient's mouth using an appropriate imaging device) or indirectly (e.g., by receiving pre-existing OTA data from an operator or another source).

Returning to fig. 5, the process 500 continues at block 504 with obtaining an OTA digital model. Fig. 7 is a graphical representation of an example of an OTA digital model 700. The digital model 700 may virtually represent or characterize the arrangement of the patient's teeth and gums in the original tooth arrangement. As shown in fig. 7, teeth in OTA may be maloccluded, malpositioned, crowded or require orthodontic correction. In some embodiments, one or more teeth present in the OTA may be designated to be extracted prior to use of the orthodontic appliance.

In some embodiments, acquiring an OTA digital model corresponding to OTA data may include first acquiring a single complex 3D database of the patient's jaw, then segmenting it, segmenting the patient's teeth into individual 3D bodies (e.g., a single tooth or a set of multiple teeth), which may then be virtually manipulated by the operator. This segmentation may be performed using any suitable technique or software, such as using an iROK Digital Dentistry Studio or other suitable software. After segmentation, the upper and lower teeth in the generated three-dimensional database may include a model of the gums and a separate model for each tooth. Thus, the operator can manipulate the OTA data to virtually move the teeth relative to the gums. As described in more detail elsewhere herein, the teeth may be manipulated from OTA to Final Tooth Arrangement (FTA). Fig. 8 shows an example of a Final Tooth Arrangement (FTA). As shown in fig. 8, the teeth in the FTA may be more aligned, less maloccluded, and improved both aesthetically and functionally (e.g., as reflected in the digital model 700) relative to OTA. In some embodiments, for example, the FTA may have a desired or advantageous inter-arch (inter-arch) and intra-arch (intra-arch) arrangement based on the operator's prescription. For example, one or more (or all) of the teeth of the upper or lower jaw (or both) are moved until their tips have a good intersection and fit.

Referring back to fig. 5, the process 500 continues in block 506 with obtaining a fixed feature digital model. As previously described, the fixation members (e.g., fixation members 160, brackets, etc.) may be coupled to the patient's teeth to allow the orthodontic appliance (e.g., appliance 10) to be mated therewith. The fixed member digital model may include a virtual representation of the geometry and/or other structural features of the fixed member. In various embodiments, the fixation member number model may be the same for each fixation member, or may differ between fixation members. For example, molars and incisors may use different fixation members. Fig. 9 shows an exemplary stationary member of the digital model 900.

With continued reference to fig. 5, the process 500 continues in block 508 with obtaining an OTA digital model with attached fixation components. For example, the fixed member digital model 900 (fig. 9) may be applied to the appropriate locations on the patient's teeth within the OTA digital model 700 (fig. 7). The resulting digital model 1000 is shown in fig. 10, where multiple digital models of fixation members 900 are arranged along the lingual side of the patient's teeth. In some embodiments, in digital model 1000, each tooth of the patient may have a fixation member coupled thereto. As previously described, the orthodontic appliance may include a plurality of arms having attachment portions configured to be coupled to fixation members (e.g., brackets) attached to the patient's teeth.

In some examples, the digital model 900 of the fixation member may be virtually positioned over the teeth in the OTA using appropriate software (e.g., iROK digital dental Studio). In some embodiments, virtually positioning a fixation member may include selecting a virtual model of a particular fixation member from a library of available fixation members and then positioning the selected fixation member on one or more teeth. In some embodiments, bracket positioning may be automatically specified (e.g., by automatically positioning the bracket in the center or predefined portion of the tooth) or manually specified (e.g., by an operator selecting and/or manipulating an attachment location for each fixation member). In some embodiments, the operator may improve the position of each fixation member as desired. For example, it may be desirable to position the fixation members as close to the gums as possible to avoid interference with the fixation members on the other jaw or with the teeth on the other jaw when the mouth is closed.

In some embodiments, the digital model 1000 with teeth in the OTA and the fixation members attached thereto may be used to determine the configuration of an adhesive tray (bonding tray) that may then be used by an operator to physically attach the fixation members to the patient's teeth. For example, the adhesive tray may be configured to fit over a patient's teeth similar to an aligner, and may include a recess on each tooth side sized and configured to receive an appropriate fixation member (e.g., bracket) therein. In various embodiments, such recesses may be positioned on the lingual side, buccal side, mesial/distal side, occlusal side of the tooth, any suitable surface of the tooth with which the corresponding bracket is intended to be bonded. In operation, a suitable fixation member may be placed in each recess, and then an adhesive (e.g., an adhesive that cures when irradiated with ultraviolet light) is applied to the adhesive surface of each fixation member. The tray may then be placed over the patient's teeth and the adhesive cured to adhere all of the securing members in place on each tooth.

To generate such an adhesive tray, a digital model 1000 may be used that characterizes the teeth with the fixation members in the OTA. For example, the digital model 1000 may be further manipulated to remove excess virtual gums, thereby limiting the size of the tray to only that required to secure the fixation members in position against the patient's teeth. The trimmed digital model may then be used to generate a physical 3D model of the patient's teeth on which the fixation members are disposed, for example using 3D printing of a polymer resin or other suitable technique.

In some embodiments, a suitable material (e.g., a transparent polymer resin) may then be formed (e.g., thermoformed) over the physical model of the patient's teeth with the securing members in the OTA. This may create an aligner-like tray having a recess shaped and configured to receive a securing member therein. The securing members may then be placed in the corresponding recesses of the tray, and the tray may be applied to the patient's teeth using a curable adhesive to attach the securing members to the patient's teeth in the OTA. The tray can then be removed, leaving the securing members in place.

In some embodiments, the adhesive tray can be directly 3D printed without the need for a physical model of the patient's teeth and without the use of thermoforming. For example, a digital model of the adhesive tray may be derived from digital model 1000 that characterizes the teeth in the OTA to which the fixation members are attached. In some embodiments, a negative (negative) of the digital model 1000 may be generated and the negative may be trimmed to provide a generally tray-like structure having surfaces corresponding to the teeth and fixation members in the digital model 1000. The generated model may be manipulated to provide features for securing the brackets in the respective grooves. Finally, the adhesive tray may be 3D printed based on the digital model, for example using a 3D printable polymer resin or other suitable material or deposition technique.

Alternatively, the operator may attach the fixation member directly to the patient's teeth without the aid of a tray.

Referring again to fig. 5, the process 500 continues at block 510 with the FTA digital model 1100 with the securing member 900 attached (fig. 11) being obtained. For example, a digital model 1000 (fig. 10) of teeth in an OTA with a model of fixation member 900 can be used to generate an FTA digital model 1100 (fig. 11). In some embodiments, the digital model 1000 can be manipulated to place teeth in the FTA.

The FTA digital model 1100 can be derived based at least in part on data characterizing teeth in the FTA. Such FTA data can include a digital representation of the desired final position and orientation of the patient's teeth relative to each other and relative to the gums. The FTA data may be obtained directly (e.g., generated by an operator) or may be received from an external source (e.g., the FTA data may be generated by a third party and provided to the operator to design an appropriate orthodontic appliance).

In some embodiments, FTA data may be obtained by manipulating OTA data to virtually move a patient's teeth. The operator can move the teeth to the desired FTA using suitable software, such as iROK Digital dental Studio. In some embodiments, the virtual movement of the teeth relative to the OTA also results in movement of the gums relative to the OTA to maintain the natural appearance of the gums and more accurately reflect the orientation and position of the gums when the teeth are at the FTA. Such movement of the gums may be accomplished by using gum deformation or other suitable techniques.

In some embodiments, the FTA may reflect changes in the patient's teeth that may occur as part of the treatment process. For example, as part of the treatment, the operator may pull one or more teeth of the patient due to insufficient space for all of the teeth to fit in the arch (or for other reasons). In this case, the extracted teeth may be excluded from the FTA data. If the operator believes that the teeth need to be made smaller due to insufficient space, interproximal reduction (IPR) may be performed on the patient. In this case, the teeth may be stripped and reduced in size in the FTA to match the IPR performed by the operator.

In some embodiments, the suggested FTA may be developed by an operator (e.g., developed independently or based in whole or in part on input from an orthodontic treating physician) and then sent to an orthodontic treating physician for review and review. If the treating orthodontist has the opinion, she may provide the operator with input (e.g., written instructions, suggested manipulation of one or more teeth or fixation members, etc.) that may be transmitted electronically or otherwise. The operator may then modify the FTA and send the modified suggested FTA back to the orthodontist for further review and review. This iterative process may be repeated until the orthodontic therapist approves the proposed FTA, and the final digital model 1100.

Additionally or alternatively, the FTA digital model (e.g., as shown in fig. 8) may be manipulated to obtain a digital model of the fixation member 900 coupled to the tooth in place. In some embodiments, the relative position of each fixation member with respect to its respective tooth may be obtained or derived from the digital model 1000 (fig. 10), where the fixation member is connected to the tooth in the OTA. In some embodiments, the fixation member may be first positioned over the teeth in the FTA to generate the digital model 1100 (fig. 11), and this model may be used in turn to generate the digital model 1000 (fig. 10), for example by manipulating the digital model 1100 to move the teeth to the OTA.

Returning to fig. 5, the process 500 continues at block 512 with determining the displacement of a single tooth or group of teeth between the OTA and the FTA. For example, the displacement of each tooth between the OTA and FTA can be described using six degrees of freedom (e.g., translation along the X, Y and Z axes, and rotation about the same three axes; or alternatively translation in the mesio-distal direction, bucco-lingual direction, and/or occlusal-gingival direction, and rotation in the form of bucco-lingual root torque, angulation of mesio-distal, and/or mesio-lateral internal rotation). In some embodiments, these values may be determined by calculating the difference between the position of each tooth in the FTA data and the OTA data. This may be performed for each tooth in each jaw to generate a data set including the desired displacement of each tooth in six degrees of freedom.

The process 500 continues at block 514 with obtaining a heat treatment fixture digital model. FIG. 12 shows an exemplary clamp digital model 1200 to which a securing member may be attached by manipulationA digital model 1100 (fig. 11) of the FTA is generated. For example, the digital model 1100 may be manipulated to generate a digital representation of a fixture (e.g., a heat treatment fixture) used to manufacture the aligner. The digital model 1100 can be manipulated in a variety of ways to generate the appropriate fixture data. In some embodiments, such operations may be performed using suitable software, for example,

the MeshMixer of (1).

In some examples, the fixation members in the digital model 1100 may be modified or replaced with appropriate fixation portions 1202, each configured to couple to an arm of the orthotic and facilitate temporary fastening of the orthotic to the jig. For example, the bracket-like fixation member may be replaced with a fixation portion 1202 that includes both a horizontal channel 1204 and a vertical channel 1206 configured to mate with the attachment portion 140 of the orthotic 100. A plurality of protrusions (projections) 1208 may be disposed along one or more side surfaces of the fixation portion 1202. The channels 1204 and 1206 and the protrusion 1208 together may provide a structure configured to receive a ligature or other fastener therethrough. For example, the operator may couple the orthotic 100 to a clamp and then wrap a ligature through the horizontal channel 1204 and in the space between adjacent projections 1208 to secure the orthotic 100 in place against the clamp. Additionally or alternatively, the horizontal channel 1204 may be configured to mate with the attachment portion 140 of the orthotic 100, for example, sufficiently deep (e.g., deeper than the corresponding channel of the fixation member 900 of the digital model 1100) to receive therein both the attachment portion 140 and a ligature wire or other fastener therethrough. In some embodiments, the vertical channel 1206 may be configured to mate with a portion of the attachment portion 140 of the orthotic 100, such that a single attachment portion 140 may be received partially within the horizontal channel 1204 and partially within the vertical channel 1206. The protrusion 1208 may also define a groove or recess configured to receive a ligature wire or other elongate fastener. The jig model 1200 may also define a through channel or hole within each of the securing portions 1202. These through passages may allow a pushing tool to be inserted from the back of the fixation section 1202 (e.g., through the buccal side of the jig model 1200) to push the attachment section 40 away from the fixation section 1202 after the heat treatment has been completed and the ligature line or other fastener has been removed.

Additionally or alternatively, the digital model 1100 may be manipulated to change the shape or configuration of the gum to generate the jig model 1200. When installing the appliance, the patient may experience considerable discomfort if any portion of the appliance strikes the gums. Accordingly, it is desirable to design an appliance that will abut the patient's gums without impacting the patient's gums. In some embodiments, this may be accomplished by enlarging the gums of the digital model 1100 to generate the jig model 1200. For example, the lingual side of the gum in the digital model 1100 may be expanded (e.g., moved more lingual) a predetermined amount (e.g., less than about 1.5 millimeters, less than about 1.4 millimeters, less than about 1.3 millimeters, less than about 1.2 millimeters, less than about 1.1 millimeters, less than about 1.0 millimeters, less than about 0.9 millimeters, less than about 0.8 millimeters, less than about 0.7 millimeters, less than about 0.6 millimeters, less than about 0.5 millimeters, less than about 0.4 millimeters, less than about 0.3 millimeters, less than about 0.2 millimeters, or less than about 0.1 millimeters). Likewise, when the appliance is created using the surface of the fixture data (e.g., the appliance 100 may be shaped to substantially correspond to a portion of the lingual side of the fixture model 1100, as described in more detail below), the appliance may be sized and configured to maintain a short distance from the patient's gums without impacting the patient's gums.

With continued reference to block 514, the digital model 1100 with the securing members attached thereto may be manipulated to remove teeth or other structural elements not required for heat treating the appliance and/or to add structural features to strengthen the jig to have sufficient rigidity during heat treatment. For example, as shown in fig. 12, the jig model 1200 does not include any teeth, but retains at least a portion of the gum surface 1210. In addition, the clamp model 1200 includes stabilizing crossbars 1212, which can enhance the stiffness of the final clamp. Various other modifications may be made to the digital model 1100 to achieve the desired heat treatment jig model 1200.

Referring back to fig. 5, the process 500 continues at block 516 with obtaining an appliance template digital model. Fig. 13 illustrates an example of an appliance template digital model 1300, here shown in a configuration that matches the jig model 1200.

The model 1300 defines an anchor portion 1302, an arm portion 1304, and an attachment rod portion 1306. These components may take the form of a universal template for the appliance that is subsequently customized for a particular patient (as described in more detail below with respect to fig. 15). For example, anchor portion 1302 may correspond to anchor 120 of a completed orthotic, and arm portion 1304 may serve as a place-holder for arm 130 of the completed orthotic. The attachment rod portion 1306 takes the form of a continuous strip connecting each arm 130. As shown in fig. 13, the arm portion 1306 may be configured to be received within the channel 1204 of the stationary portion 1202 of the jig model 1200. The attachment rod portion 1306 may correspond in part to the portion of the attachment portion 140 of the arm 130 of the finished orthotic.

In various embodiments, the aligner template digital model 1300 may be generated using surface data of the jig model 1200. For example, the appliance template digital model 1300 may be configured to substantially correspond to the surface of the clip model 1200, e.g., the anchor portion 1302 corresponds to a contour (contourr) of the clip model 1200 derived from data characterizing the patient's gums. As previously described, the treatment jig model 1200 may be modified relative to the OTA model 1100, particularly by enlarging the gums, and the like. Thus, when the anchor portion 1302 contacts the gingival portion of the clip model 1200, the anchor portion 1302 may be positioned slightly spaced from the actual gingiva characterized in the OTA model 700. In some embodiments, the orthotic template model 1300 may not have a thickness dimension, but rather corresponds to a three-dimensional surface that follows the contours of the jig model 1200. In some embodiments, the orthotic template model 1300 may have at least some thickness.

In block 518, the orthotic template digital model 1300 may be flattened or otherwise manipulated to generate a planar orthotic template model 1400 (fig. 14). The planar template model 1400 may reflect two-dimensional or substantially planar data corresponding to or at least derived from the contoured appliance template model 1300. For example, can be obtained byFlattening, planarizing, or otherwise transforming the digital model 1300 to transform the aligner template digital model 1300 (fig. 13) into a planar aligner template model 1400 (fig. 14) to generate a planar aligner template model 1400. A processor system and appropriate software (such as, but not limited to

Inventor、

Or other suitable software) performs such conversion.

At block 520, a planar appliance digital model is obtained. Fig. 15 shows an example of a planar orthotic model 1500. In this stage, the particular shape and configuration of the arms of the orthotic may be determined, for example, by modifying or replacing portions or components of the planar template model 1400 (fig. 14). For example, the particular dimensions, geometry, and material characteristics of the arms of the orthotic may be selected so as to apply the necessary force and/or torque to achieve the desired displacement determined at block 512. In some embodiments, a pre-generated library (pre-populated library) of arm designs may be used to select the appropriate design and configuration to achieve the desired displacement. In some embodiments, arm designs in the pre-generated library may be analyzed using Finite Element Analysis (FEA) or other techniques to determine the spring force that such arms will exert when deflected by a particular amount (e.g., the amount of deflection between the FTA (when the arm is at rest) and the OTA). In some embodiments, an operator may review and/or modify a particular arm design that is fully or partially automatically selected based on relevant criteria. For example, if the proposed arm design includes overlapping or otherwise interfering arms, the operator may manually adjust the shape and/or configuration of the arms.

From the determined displacements, the force and/or torque required to move each tooth from the OTA to the FTA can be determined. The force required to move the teeth is typically in the centiNewtons (centiNewtons) range and the distance moved is typically in the millimeter range. The moment (newton-millimeters) for rotating the tooth can be calculated by multiplying the magnitude of the applied force by the moment arm. In general, the displacement may be a 3D tooth motion that combines translational and rotational motion.

The force and/or torque required to achieve the FTA may depend on the patient's anatomy, such as the size of the particular tooth moved, the anatomy of the root, etc. The force and/or torque may also depend on other physiological parameters (e.g. bone density, biological determinants, sex, race, jaw (maxilla or mandible), mechanical properties of the surrounding tissue surrounding the active teeth (lips, tongue, gums and bones), etc.). The particular force and/or torque applied to a given tooth also depends on the particular positioning of the fixation member (e.g., bracket). For example, a fixation member positioned farther from the center of tooth impedance (center-of-resistance) will produce more torque for a given force than a fixation member positioned closer to the center of tooth impedance. Based on the desired displacement (e.g., in six degrees of freedom), the patient's anatomy, and the position of the fixation member, a particular arm configuration may be selected to produce the desired force and/or torque on the target tooth to move the tooth from the OTA to the FTA. By determining the appropriate thickness, width, shape, and configuration of the arms and other components of the orthodontic appliance, the appliance configuration that applies force and torque to the appropriate teeth to move the teeth to the FTA is determined.

In certain examples, the design of the orthotic may be performed by an operator via a processor system and appropriate design software, such as, but not limited to, CAD software

Inventor、

And the like. FEA software (such as, but not limited to, Abaqus, Ansys, etc.) can be used to design the springs and arms to apply a desired or optimal force to the teeth. For example, the thickness, cut width, length of each arm can be designed and varied based at least in part on the motion of the tooth to which the arm is attached using such software and processing systemAnd overall design.

In some examples, the arms 130 may be designed to make them more flexible if the teeth need to be displaced a longer distance or if the teeth are smaller (e.g., lower incisors). In some embodiments, the selection or design of the arm 130 may take into account the change in the speed of tooth movement based on direction. It is well known that when a given force is applied to a tooth, the speed of movement of the tooth varies depending on the direction of movement. For example, for a given force, eruption (extrusion) is the fastest movement, and intussusception (intusion) is the slowest movement, with mesiodistal and bucco-lingual movements between these two extremes. In one example, if a tooth moves 2mm per month to the occlusal side and 1mm per month to the mesial side, the tooth will not move in a straight line because the occlusal side will move faster than the distal side under the same force. The occlusal movement will be done first and then the teeth will move straight from there in the distal direction until the movement is complete. It may be desirable to move the teeth in a particular trajectory and, therefore, the force applied by the mesial side may be different from the force applied by the occlusal side. For example, it may be desirable to move the teeth in a straight line, so the force on the distal side must be greater than the force on the occlusal side in order to form a straight line trajectory from the OTA to the FTA.

In some embodiments, the arms 130 may be designed to exert less force on some or all of the teeth due to periodontal problems such as bone resorption (bone resorption), root resorption (root resorption), or loss of attachment (attachment loss). The ability to customize the force or torque (or both) applied to each tooth can provide significant advantages over conventional orthodontics. In certain examples, the computer-aided procedure employs an algorithm, such as selecting or configuring an arm or other feature of an appliance from one or more predefined sets of options or one or more ranges of options. Thus, for example, a set of options or ranges of options may be predefined for one or more parameters associated with an arm or other feature.

The one or more parameters associated with the arm 130 may include, but are not limited to, the full length of the arm, the shape or configuration of the biasing portion 150, the shape or configuration of the bracket connector 40, the width dimension of one or more sections (sections) of the arm 130, the thickness dimension of one or more sections of the arm 130, and the like.

Obtaining the planar appliance digital model 1500 may also include determining the shape and configuration of the anchors 120. For example, anchor 120 can be selected to substantially conform to the patient's gums without impacting therewith. The thickness, depth, or other characteristics of anchor 120 may also be selected to provide sufficient rigidity to the forces generated by the arms. In some embodiments, the design of anchor 120 can be automatically generated (e.g., by automatically generating to substantially conform to the patient's gums or other locations in an FTA model (e.g., model 1100) or an OTA model (e.g., model 700 or 1000)). In some embodiments, the design and configuration of the anchors may be manually selected or modified by an operator as desired.

Although in the illustrated embodiment, the particular features of the arm 130 are selected when the appliance model is substantially planar or in 2D, in other embodiments, the appliance features may be selected and configured based on a digital model whose contours correspond to the patient's anatomy. For example, the 3D appliance template model 1300 (fig. 13) may be modified to select a particular arm 130, anchor 120, or any aspect thereof to achieve a desired appliance. In some embodiments, the template is omitted entirely, and a customized appliance model is generated based on the OTA model and/or the FTA model, without using an interventional template model.

In some embodiments, the planar appliance model 1500 may be 2D, so the model does not define the thickness of the appliance. For example, such a model may be used to cut an appliance from a sheet of material. In this case, the thickness may be determined by selecting a sheet of material and by polishing, etching, grinding, depositing, or other techniques for adjusting the final thickness of the appliance. In some embodiments, the planar orthotic model 1500 may define a thickness dimension while remaining substantially planar or flat (flat). For example, the planar orthotic model 1500 may define the thickness of the orthotic, which may be uniform, or may vary over some or all of the anchors 120 and arms 130.

In some embodiments, a 3D or contoured appliance model may be generated, for example, by manipulating the planar appliance model 1500 into a curved or contoured configuration. In some embodiments, the 3D appliance model may correspond to an appliance installed on a tooth in the OTA (e.g., by manipulating the planar appliance model 1500 using position data of the fixation member 900 in the OTA model 1000 (fig. 10) or by manipulating the planar appliance model 1500 using position data of the fixation member 900 in the FTA model 1100 (fig. 11)).

Referring to blocks 516, 518, and 520 together, in some examples, a computer-assisted program may be used to select or determine the shape and configuration of the arms, anchors, and/or any other features of the orthotic. The program may be configured to select one (or more) of the arms, fixation members, anchors, or parameters thereof, or any other aspect of the orthotic based on one or more input data. For example, the input data may include, but is not limited to, the type of tooth (e.g., molar, canine, incisor, etc.) or the size of the tooth. Larger teeth (e.g., molars) may require larger arms or larger, wider or thicker rings or curved features to provide greater force than smaller teeth (e.g., incisors). Additionally or alternatively, the input data may include a size of a periodontal ligament (PDL) of the one or more teeth. The size of the PDL may be obtained by any suitable process, including but not limited to CBCT scanning or other imaging techniques. Other input data may include, but is not limited to, the amount or direction of force applied to one or more teeth in three-dimensional space. For example, a desired tooth movement direction may require one or more shapes or configurations of the arms to be different than that required for a different tooth movement direction. Other input data may include, but is not limited to, the amount or direction of rotational force (or torque) applied to one or more teeth. For example, a desired tooth movement in a rotational direction may require one or more shapes or configurations of the arms to be different than that required for different tooth movement directions. Further, in some embodiments, two or more arms may be attached to a single tooth, either by each arm being coupled to a separate fixation member, or by both arms being coupled to the same fixation member. In this case, the input data may include the number of arms and/or fixation members coupled to each tooth, or alternatively, the number of arms and/or fixation members may be generated as output data.

In some embodiments, the computer-assisted program may include an algorithm that includes as input (but is not limited to) one or more values representing one or more of: (a) up to three translational and up to three rotational movements from OTA to ITA or FTA, or from ITA to another ITA or FTA; (b) the surface of the periodontal ligament (PDL) or the root area of one or each tooth; (c) bone density of the patient; (d) biological determinants, e.g., obtained from saliva, Gingival Crevicular Fluid (GCF), blood, urine, mucous membranes, or other sources; (e) the sex of the patient; (f) the race of the patient; (g) the jaw (maxilla or mandible) to which the orthosis is to be fitted; (i) the number of teeth to which the appliance is to be installed; (j) the mechanical properties of the bone and surrounding tissue of the tooth to be moved (lips, tongue, gums). In various embodiments, one or more such inputs may affect the force (e.g., magnitude, direction, contact point) required to move each tooth from OTA to FTA or toward FTA.

In other examples, other suitable input data may be used. The computer-assisted program uses computer programming or is configured with appropriate non-transitory software, hardware, firmware, or a combination thereof, to generate an output (e.g., one or more selected arm configurations, anchor configurations, or fixed member configurations) based on one or more input data.

The output generated by the computer-assisted program based on such input may include, but is not limited to, one or more of: (a) designing an arm; (b) the width or cut width of one or more such arms; (c) any appliance portion or thickness dimension of the entire appliance; (d) mechanical properties of such arms, including but not limited to the amount of flexibility, or the magnitude of the biasing force or rebound (resilience); (e) designing an anchoring part; (f) the width or thickness of the anchor; (g) the connection location between the arm and the anchor; and/or (h) the transition temperature of the nitinol (or other material) in one or more (or each) segment of the appliance. As previously described, in some embodiments, the output may include a particular configuration of anchors and/or arms selected from a pre-generated library. For example, based on the input, a desired force (e.g., magnitude and direction) may be determined for each tooth. Based on the desired force, an appropriate anchor member and/or arm configuration may be selected that provides the desired force or an appropriate approximation thereof. In some embodiments, the configuration of the appliance (including any of the outputs listed above) may be generated independently of any of the pre-generated libraries. In some embodiments, generating the output may include analyzing provisional (provisional) selections or designs using Finite Element Analysis (FEA) or other techniques to determine performance parameters (e.g., the elastic force that such arms will exert when deflected by a particular amount (e.g., the amount of deflection between the FTA (when the arm is stationary) and the OTA).

In certain examples, a customized appliance may be made for each given patient using computer-assisted programming. In other examples, the orthotic may be manufactured in a number of predefined sizes, shapes, configurations, etc., based on a group of people (a population group). Thus, a different semi-custom size, shape or configuration would be configured to fit each different selected portion of the population. In this manner, a more limited number of different orthotic sizes, shapes and configurations may be made to accommodate a relatively large portion of the population.

From the determined shape and configuration of the arms and anchors, complete appliance shape data can be generated. In some embodiments, the appliance shape data may take the form of 3D data (e.g., an appliance in its shape-set form after heat treatment or other suitable shaping technique) or planar or substantially 2D data (e.g., an appliance in its lay-flat form cut from a sheet of material, for example).

At block 522, an appliance may be manufactured (e.g., based on the planar appliance digital model 1500 (block 520)). And at block 524, a heat treatment fixture may be fabricated (e.g., based on the heat treatment fixture digital model 1200 (block 514)). The manufacture of the heat treatment fixture and the aligner will be described in more detail below.

In some embodiments, generating the complete appliance shape data may include: a heat treatment jig model is obtained (e.g., as described below with respect to fig. 12), and a preliminary appliance model is generated based on the heat treatment jig model. For example, the preliminary appliance model may conform to at least a portion of the lingual surface of the heat treatment jig model. The preliminary appliance model may then be modified to include the determined arms and anchors to have a determined thickness profile, and so on. The modified appliance model may then be flattened for use in manufacturing, as described below.

Method for manufacturing orthodontic appliance

As described above, one or more digital models (e.g., the planar appliance digital model 1500 or the contoured appliance digital model) characterizing or defining the appliance may be generated. In various embodiments, one or more such digital models may be used to manufacture an appliance for a patient. Figure 16 illustrates an example of an appliance 100 manufactured using one or more digital models described herein. Certain example manufacturing processes are described below. However, one skilled in the art will appreciate that any suitable manufacturing process may be used to manufacture the aligners (or components thereof) disclosed herein.

In some embodiments, the orthodontic appliance 100 can be manufactured using a planar digital appliance model (e.g., the planar appliance digital model 1500). For example, the planar corrector digital model may include planar or substantially two-dimensional shape data. The planform data may be provided to a suitable manufacturing apparatus (e.g., without limitation, one or more machines that perform cutting, laser cutting, milling, chemical etching, wire Electrical Discharge Machining (EDM), water jetting, punching (stamping), etc.) to cut the flat sheet of material into components having a shape corresponding to the planform aligner digital model 1500. The member may be cut from a flat piece of any suitable material, such as, but not limited to, nitinol, stainless steel, cobalt chrome (cobalt chrome), or other types of metals, polymers, superelastic materials, and the like. The sheet of material may have a thickness selected to achieve the desired material properties of the resulting component. In various embodiments, the thickness of the sheet of material may be uniform or may vary (e.g., along a gradient, thinned in particular regions using etching, grinding, etc., or thickened in particular regions using deposition, etc.). In some examples, the thickness of the sheet of material may be between about 0.1mm to about 1.0mm, between about 0.2mm to about 0.9mm, between about 0.3mm to about 0.8mm, between about 0.4mm to about 0.7mm, or about 0.5 mm. In some embodiments, the thickness of the sheet of material may be less than about 1.5mm, less than about 1.4mm, less than about 1.3mm, less than about 1.2mm, less than about 1.1mm, less than about 1.0mm, less than about 0.9mm, less than about 0.8mm, less than about 0.7mm, less than about 0.6mm, less than about 0.5mm, less than about 0.4mm, less than about 0.3mm, less than about 0.2mm, or less than about 0.1 mm.

Next, the cutting member may be bent from its substantially planar shape into a contoured arrangement. Figure 16 illustrates an example of a completed orthotic 100 resulting from such bending of a planar member. As shown, and as described elsewhere herein, the orthotic 100 may comprise an anchor 120 and a plurality of arms 130 extending away from the anchor 120. Each arm 130 may include: an attachment portion 40 configured to mate with a fixation member adhered to a patient's tooth, and a biasing portion 150 disposed between the attachment portion 40 and the anchor 120. When the appliance 100 is installed in a patient's mouth, each arm 130 may be connected to a different one of the teeth to be moved and apply a particular force to its respective tooth, thereby allowing the operator to move each tooth independently.

In some embodiments, the planar member, after being cut or otherwise formed from a sheet of material, may be bent or otherwise manipulated into a shape or profile corresponding or substantially corresponding to the FTA configuration. For example, the member may be in the form of a cut from a flat piece of nitinol or other suitable material, and in a generally planar configuration. The member may be bent into a desired 3D or contoured configuration, for example, corresponding to contoured orthotic digital model 1600. In some examples, one or more clamps are configured to bend the planar member into a desired 3D shape. In such examples, after cutting the planar member, the planar member may be secured on or between one or more clamps and bent or otherwise manipulated to form the desired 3D shape. In some embodiments, the thickness of the member may be modified at least in certain portions to achieve desired material properties before or after cutting the member from the sheet of material. For example, grinding, chemical etching, photolithography, wire electrical discharge machining, or any other suitable material removal process may be used to reduce the thickness of at least some regions of the component. The thickness of at least some regions of the component may be increased using thin film deposition, electroplating, or any other suitable additive technique. In some embodiments, the planar member may be formed using 3D printing or other techniques, instead of or in addition to cutting the planar member from a sheet of material. 3D printing may provide certain advantages, such as ease of controlling the thickness of different portions of the appliance. In some embodiments, the planar member may be formed by 3D printing a metal, a polymer, or any other suitable material that may be additively manufactured by 3D printing.

In some embodiments, the appliance shape may be fixed in a desired contoured or 3D configuration (e.g., corresponding to an FTA). During or after the bending operation, one or more shape-fixing procedures (e.g., without limitation, heat treatment) may be applied to the appliance while remaining in the desired 3D shape to shape the desired 3D shape. Shape setting procedures including heat treatment may include rapid cooling after heating the component during or after bending. Additional details regarding example heat treatments and related fixtures are described below.

By using cut planar members, rather than traditional single diameter wires, a greater variety of final 3D shapes can be made than shapes made by bending a single diameter wire. The cutting plane member may have a designed or varying width and length that, when bent into a desired shape, may allow portions of the 3D device to have variations in thickness, width, and length dimensions. In this manner, the planar member may be cut into a shape that provides the desired thickness, width, and length of the biasing portion, arm, or other component of the orthotic. Cutting plane members customized by bending can provide a wider variety of shapes than bent single diameter wires.

In some examples, the entire appliance (including the arms and anchors) is manufactured by bending the cut planar members into the desired 3D shaped members. In other examples, additional components may be attached to the 3D shape, for example, after bending. Such additional components may include, but are not limited to, attachment portion 40, biasing portion 150, arm 130, and the like. Such additional components may be attached to the 3D shaped member by any suitable attachment mechanism including, but not limited to, adhesive materials, welding, fasteners (etc.).

In some embodiments, the appliance may be 3D printed directly into the configuration of the desired contour or 3D shape. In some embodiments, the 3D shaped member may be 3D printed out, for example, using any suitable material. In the case of 3D printing the appliance using nitinol, a shape-setting process (e.g., heat treatment) may not be required. Further, 3D printing may allow for different geometries to be used (e.g., the cross-sectional shape of the anchor member may be elliptical rather than rectangular, which may increase patient comfort on the gingival-facing and lingual-facing sides of the anchor).

Method for shaping orthodontic appliances

As previously described, in some embodiments, a heat treatment jig model (e.g., heat treatment jig model 1200 (fig. 12)) may be used to generate the aligner digital model. For example, the planar orthotic digital model 1500 may be obtained based at least in part on the heat treatment jig model 1200. The heat treatment jig model 1200 may also be used to manufacture a heat treatment jig that is then used to shape the aligner (e.g., a planar member cut from a sheet of material may be formed into a desired 3D shape by using the heat treatment jig).

Fig. 17 shows an example of a heat treatment jig 1700. The fixture 1700 may be fabricated based on a heat treated fixture digital model, such as the fixture digital model 1200 (fig. 12). For example, the digital model or related data can be provided to a manufacturing system to generate a physical (physical) model based on the fixture model. In one example, the fixture data may be used to 3D print out a waxed fixture model. The jig may then be investment cast using a wax pattern with brass or other suitable material. In some embodiments, the jig may be 3D printed directly from brass or other suitable material (e.g., stainless steel, bronze, ceramic, or other material capable of withstanding the high temperatures required for thermal processing). As shown in fig. 17, the clamp 1700 may include a fixation portion 1702 configured to mate with the attachment portion 40 of the orthotic 100.

In some embodiments, the manufactured jig may be used to heat set the aligner. For example, as shown in fig. 18, a composite assembly 1800 may include an aligner 100 that has been bent or otherwise manipulated into a shape to abut against the surface of a heat treatment fixture 1700. The orthotic 100 may be coupled to the clamp 1700 by placing the attachment portions of the arms in the fixation portions 1702 of the clamp. A ligature 1802 or other suitable fastener may be wrapped around the orthotic 100 at a plurality of locations to secure the orthotic 100 relative to the clamp 1700. Next, heat may be applied to heat set the appliance 100, and then the appliance 100 is removed from the jig 1700.

One example of a heat treatment procedure may include heating the appliance 100 to a selected temperature (e.g., without limitation, 525 degrees celsius) for a selected time (e.g., without limitation, 20 minutes) and then rapidly cooling. The rapid cooling may be achieved by any suitable cooling procedure, such as, but not limited to, water quenching or air cooling. In other examples, the time and temperature of the thermal treatment may be different than those discussed above, e.g., based on a particular treatment plan. For example, the heat treatment temperature may be in the range of 200 degrees celsius to 700 degrees celsius, and the heat treatment time may be a time in the range of about 120 minutes. In particular, the heat treatment procedure may be performed in an air or vacuum furnace, salt bath (salt bath), fluidized sand bed (fluidized sand bed), or other suitable system. After completion of the heat treatment, the appliance has a desired 3D shape and configuration (e.g., substantially corresponding to the heat treatment fixture and/or the desired FTA). In other examples, other suitable heat treatment procedures may be employed, including but not limited to resistive heating or heating by passing an electrical current through the metal of the appliance structure.

One or more additional post-processing operations may be provided on the 3D shape including, but not limited to, sand blasting (blasting), shot peening, polishing, chemical etching, electropolishing, electroplating, coating (coating), ultrasonic cleaning, sterilization, or other cleaning or decontamination processes.

In examples where the appliance is made up of multiple components, some (or each) of the components of the appliance may be manufactured according to the above method and then connected together to form the desired 3D appliance configuration. In these or other examples, the appliance (or some or each component of the appliance) may be manufactured using other suitable methods, including but not limited to: directly printing metal; first printing a wax member and then investment casting the wax member into a metal or other material; printing an elastomeric material or other polymer; cutting or machining solid materials; or cutting the component from a sheet of metal and fixing its shape in the desired 3D configuration.

As discussed herein, one or more heat treatment fixtures may be configured to bend the cut planar member into a desired 3D shape configuration. In a particular example, one or more heat treatment clips are provided (e.g., without limitation, customized) for each jaw of the patient. For example, the shape and configuration of the heat treatment fixture may be customized for each patient and may be manufactured in any suitable manner, including molding, machining, direct metal printing of stainless steel or other suitable metal, 3D printing of suitable materials, such as, but not limited to, stainless steel melted by powder bed (powder bed fusion), or steel/copper mixtures formed by bonding (binder injection), and first printing the configuration with wax and then investment casting the wax into the various metals. In various examples described herein, the heat treatment fixture may be constructed of a material that is sufficiently resistant to the heat treatment temperature. In certain examples, one or more robots (robots) may or may not be used with one or more heat treatment fixtures for bending the cut planar members into a desired 3D shape configuration.

In some embodiments, a single shaping step may be accomplished to deform the member from its planar configuration to its desired 3D configuration. However, in certain embodiments, shaping may include two or more shaping steps (e.g., two or more heat treatment processes, possibly using two or more different heat treatment fixtures). In this case, the amount of deformation applied to the appliance may be limited in each shaping step, with each subsequent shaping step moving the appliance further toward the desired three-dimensional configuration.

The finished appliance (optionally with an adhesive tray and/or fixation member) may then be sent to a clinician. To install the appliance, the orthodontist cleans the lingual side of the patient's teeth in preparation for bonding (e.g., with pumice). The tooth surface may then be grit blasted (e.g., using 50 micron alumina). The securing member may then be attached using an adhesive tray, as described elsewhere herein.

After the appliance is manufactured and the securing members are attached to the teeth, each arm may be coupled to its respective securing member element to install the appliance. After installation, the appliance will apply force and torque to the teeth to move the teeth to the desired FTA. After treatment is complete (e.g., OTA to FTA, OTA to ITA, ITA to ITA, or ITA to FTA), the arms may be passively placed in (sit in) the fixation member and no longer apply force to the teeth. Alternatively, any residual force exerted by the arm may be below a threshold that causes further displacement of the tooth.

The patient may return for an examination appointment (e.g., about 2-3 months) and, if treatment is planned, no action is performed until the patient returns for appliance removal at the planned time. At this stage, the fixing member may be removed. If the treatment is not planned, the appliance may be removed, the patient's mouth rescanned, and a new appliance designed and installed according to the modified treatment plan.

Conclusion

Although many of the embodiments have been described above primarily in terms of systems, devices, and methods for orthodontic appliances on the lingual side of a patient's teeth, the techniques are applicable to other applications and/or other methods, such as orthodontic appliances on the facial side of a patient's teeth. Moreover, other embodiments in addition to those described herein are within the scope of the present technology. Moreover, several other embodiments of the technology may have different configurations, components, or procedures than those described herein. Accordingly, one of ordinary skill in the art will accordingly appreciate that the techniques may have other embodiments with additional elements, or that the techniques may have other embodiments without several of the features shown and described above with reference to fig. 1A-18.

The description of the embodiments of the present technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Singular or plural nouns may also include plural or singular nouns, respectively, if the context permits. For example, embodiments described herein as using multiple linkage arms may also be modified to include fewer (e.g., one) or more (e.g., three) linkage arms. While specific embodiments of, and examples for, the technology described above are described for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein can also be combined to provide further embodiments.

Furthermore, unless the term "or" is expressly limited to mean only a single item in addition to other items in two or more lists of items, the use of "or" in such lists should be interpreted to include (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Further, "comprising" is used throughout to mean including at least the recited features, so as not to exclude any further number of additional types of the same and/or other features. It is also to be understood that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Moreover, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the present disclosure and related techniques may include other embodiments not explicitly shown or described herein.

Claims (28)

1. A method of manufacturing an orthodontic appliance, comprising:

data corresponding to an original dental arrangement (OTA) of a patient's teeth is acquired,

acquiring data corresponding to a desired Final Tooth Arrangement (FTA) of a patient's teeth;

determining a displacement between the OTA data and the FTA data;

determining a configuration of an orthodontic appliance based on the determined displacement, the configuration of the orthodontic appliance comprising:

an anchor configured to be positioned adjacent a patient's tooth; and

a plurality of arms, each arm extending away from and coupled to the anchor, the arms configured to be secured to a patient's tooth,

wherein the arm pushes each of the patient's teeth from OTA to FTA when the appliance is installed,

wherein determining the configuration of the appliance comprises applying a computer-assisted algorithm to input data to generate output data corresponding to the configuration of the orthodontic appliance, the input data comprising (i) a displacement between OTA data and FTA data, and (ii) at least one patient-specific parameter.

2. The method of claim 1, wherein the at least one patient-specific parameter comprises a surface geometry of a periodontal ligament or a root area of one or more teeth.

3. The method of claim 1, wherein the at least one patient-specific parameter comprises a bone density of the patient.

4. The method of claim 1, wherein the at least one patient-specific parameter comprises one or more biological determinants obtained from the patient's saliva, gingival crevicular fluid, blood, urine, or mucosa.

5. The method of claim 1, wherein the at least one patient-specific parameter comprises mechanical properties of bone and tissue adjacent to a tooth to be moved.

6. The method of claim 1, wherein the at least one patient-specific parameter comprises at least one of: the sex of the patient, the age of the patient, the race of the patient, the jaw to which the appliance is to be installed, or the number of teeth to which the appliance is to be installed.

7. The method of claim 1, wherein the output data includes a design of one or more of the plurality of arms and a design of the anchor.

8. The method of claim 1, wherein the output data comprises transition temperatures of materials in one or more segments of the appliance.

9. The method of claim 1, wherein determining displacements comprises determining displacements in six degrees of freedom.

10. The method of claim 1, wherein determining displacements comprises determining a translation of each of the patient's teeth.

11. The method of claim 1, wherein determining a displacement comprises determining a rotation of each of the patient's teeth.

12. The method of claim 1, further comprising determining a force required to achieve the determined displacement for each of the patient's teeth.

13. The method of claim 1, further comprising determining a torque required to achieve the determined displacement for each of the patient's teeth.

14. The method of claim 1, wherein each arm is configured to couple to a different one of the patient's teeth.

15. The method of claim 1, further comprising determining forces and moments to achieve a determined displacement of each tooth, and selecting or configuring an arm to achieve the determined forces and moments.

16. A method of manufacturing a heat treatment fixture for an orthodontic appliance, the method comprising:

obtaining Final Tooth Arrangement (FTA) data corresponding to the desired tooth arrangement;

manipulating the FTA data to obtain fixture data defining a geometry of the heat treatment fixture; and

manufacturing the heat treatment fixture based at least in part on the fixture data.

17. The method of claim 16, wherein the FTA data comprises a fixture position configured to be placed on each tooth at the fixture position.

18. The method of claim 17, wherein the fixation member is configured to mate with an arm of an orthodontic appliance.

19. The method of claim 16, wherein the FTA data comprises data characterizing the gums, and wherein manipulating the modified FTA data comprises changing the size and/or position of the gums.

20. The method of claim 19, wherein altering the size and/or location of the gums comprises expanding the gums.

21. The method of claim 16, wherein manipulating the FTA data comprises adding a stiffening element.

22. The method of claim 16 wherein manipulating the FTA data changes a geometry of the heat treatment fixture to increase its stiffness.

23. The method of claim 16, wherein the FTA data comprises a fixation member configured to mate with an arm of an orthodontic appliance, and wherein modifying FTA data comprises changing a shape of the fixation member.

24. The method of claim 23, wherein changing the shape of the fixation member comprises shaping the fixation member to mate with an arm of an orthodontic appliance and receiving an elongated fastener for detachably coupling the appliance to the heat treatment clip.

25. The method of claim 16, further comprising coupling an orthodontic appliance to the heat treatment fixture and heating the appliance and the heat treatment fixture.

26. The method of claim 25, wherein heating the aligner and the heat treatment fixture comprises heating to at least 200 degrees celsius.

27. The method of claim 25, further comprising cooling the aligner and the heat treatment fixture after heating by liquid quenching or air cooling.

28. The method of claim 25, wherein coupling the orthodontic appliance to the heat treatment jig comprises wrapping one or more elongate fasteners around the orthodontic appliance and the heat treatment jig.

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